Orion Corp 
Welcome,         Profile    Billing    Logout  
 23 Products   116 Diseases  23 Products   195 Trials   5067 News 
247 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Nubeqa (darolutamide) / Bayer, Orion Corp
NCT05348876: A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

Recruiting
4
50
RoW
Darolutamide (Nubeqa, BAY1841788)
Bayer
Non-metastatic Castration-resistant Prostate Cancer
01/26
01/26
COAction, NCT06627530: COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

Recruiting
4
144
RoW
Darolutamide Oral Tablet, leuprorelin
Brazilian Clinical Research Institute, Bayer
Prostate Cancer
03/26
09/26
NCT06660862: Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.

Not yet recruiting
4
80
US
Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy
University of Chicago
Prostate Cancer
11/29
11/29
ChiCTR2200057479: DAROL: An observational study of darotamine in patients with non-metastatic castration-resistant prostate cancer

Recruiting
4
1000
 
Darolutamide
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Bayer Aktiengesellschaft, Bayer AG
Castration-resistant prostate cancer
 
 
2019-004818-34: A clinical research study to investigate whether the addition of a new medication (darolutamide) to standard treatment is better for improving the outcomes for men with localised prostate cancer compared to standard treatment.

Not yet recruiting
3
1100
Europe
Darolutamide, BAY 1841788 (darolutamide, ODM-201), Film-coated tablet
Cancer Trials Ireland, Bayer, NHMRC Clinical Trials Centre (CTC), University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer (ANZUP)
Clinically localised prostate cancer defined as very high risk, or with very high risk features., Clinically localised prostate cancer defined as very high risk, or with very high risk features., Diseases [C] - Cancer [C04]
 
 
2020-003093-48: A trial to learn how well darolutamide plus androgen deprivation therapy (ADT) works in comparison to placebo plus ADT in men with prostate cancer that has spread to other parts of their body

Not yet recruiting
3
665
Europe
Darolutamide 300mg film-coated tablet, BAY 1841788, Film-coated tablet, NUBEQA
Bayer Consumer Care AG, Bayer Consumer Care AG
Metastatic hormone-sensitive prostate cancer (mHSPC), Metastatic prostate cancer responsive to hormone therapy which works by either stopping the body from making testosterone, or by stopping testosterone from reaching the cancer cells., Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
ARASENS, NCT02799602 / 2015-002590-38: Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Completed
3
1306
Europe, Canada, Japan, US, RoW
BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
Bayer, Orion Corporation, Orion Pharma
Metastatic Hormone-sensitive Prostate Cancer
10/21
04/23
2021-003542-21: Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial evaluating dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases. Etude de phase III randomisée multicentrique contrôlée contre placebo évaluant l’ajout du darolutamide à l’hormonothérapie et à la radiothérapie chez des patients atteints d’un cancer de prostate avec des métastases ganglionnaires pelviennes.

Ongoing
3
152
Europe
DAROLUTAMIDE, NUBEQA, Film-coated tablet, NUBEQA
ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, BAYER
Prostate cancer with pelvic lymph nodes metastases. Cancer de la prostate avec des métastases ganglionnaires pelviennes., Prostate cancer with pelvic lymph nodes metastases. Cancer de la prostate avec des métastases ganglionnaires pelviennes., Diseases [C] - Cancer [C04]
 
 
NCT06177015: Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Recruiting
3
200
RoW
Darolutamide continuous, Darolutamide, Darolutamide intermittent
The First Affiliated Hospital with Nanjing Medical University
Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy
12/25
12/27
ARANOTE, NCT04736199 / 2020-003093-48: Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

Active, not recruiting
3
669
Europe, Canada, RoW
Darolutamide (Nubeqa, BAY1841788), Placebo, Androgen deprivation therapy (ADT)
Bayer, Orion Corporation, Orion Pharma
Prostatic Neoplasms
06/24
01/26
GETUG-AFU 42, NCT06496581: Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

Recruiting
3
500
Europe
177Lu-PMSA-617, Pluvicto®, Standard of Care, ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapy* or ADT with docetaxel* plus an ARSI (i.e abiraterone + prednisone, or darolutamide,) ± radiotherapy
UNICANCER, Novartis
Prostate Cancer Metastatic
02/33
08/39
PEACE8, NCT06276465: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Recruiting
3
336
Europe
Darolutamide 300 mg, Nubeqa, Stereotactic body radiation therapy, SBRT, Androgen deprivation therapy, ADT
UNICANCER, Bayer
Prostatic Cancer, Castration-Resistant
10/29
10/32
ARASAFE, NCT05676203: A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

Active, not recruiting
3
250
Europe
Standard ADT (androgen deprivation therapy), Standard Darolutamide, Docetaxel
Jena University Hospital, Bayer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
07/25
01/27
PEACE 7, NCT06625970: Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

Recruiting
3
700
Europe, RoW
Darolutamide, Stereotactic Body RadioTherapy (SBRT), ADT (Standard of Care), LHRH agonists, LHRH antagonists, radiotherapy, Normo-fractionated radiotherapy, Hypo-fractionated radiotherapy, intensity modulated radiotherapy (IMRT), whole pelvic nodal radiotherapy (WPRT)
UNICANCER, Bayer
High Risk Prostate Carcinoma, Prostate Cancer
10/33
10/45
TRIPLE-SWITCH, NCT06592924: Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Recruiting
3
830
Canada
Abiraterone, Enzalutamide, Apalutamide, Darolutamide (BAY 1841788), Docetaxel, ADT
Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, Alliance for Clinical Trials in Oncology, SWOG Cancer Research Network
Prostate Cancer (Adenocarcinoma)
03/31
04/31
ARAMIS Rollover, NCT04464226 / 2019-003618-15: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Recruiting
3
402
Europe, Canada, Japan, US, RoW
Darolutamide (Nubeqa, BAY1841788), ODM-201
Bayer
Cancer
06/28
06/28
ALADDIN, NCT05116475: Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

Recruiting
3
152
Europe
Darolutamide 300 mg, Placebo of Darolutamide
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie, Bayer
Prostate Cancer
02/26
02/27
ProBio, NCT03903835 / 2018-002350-78: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Recruiting
3
750
Europe
Enzalutamide Oral Capsule, Xtandi, Abiraterone Oral Tablet, Zytiga, Carboplatin, Cabazitaxel 60 mg Solution for Injection, Docetaxel Injectable Solution, Radium Chloride Ra-223, Xofigo, Niraparib plus Abiraterone acetate plus Prednisone, Akeega, Capivasertib plus Docetaxel, Apalutamide, Erleada, Darolutamide, Nubeqa
Karolinska Institutet, The Swedish Research Council, Kom Op Tegen Kanker, Janssen Pharmaceutica N.V., Belgium, AstraZeneca, Cancerfonden
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
12/26
12/26
ARASTEP, NCT05794906: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

Recruiting
3
970
Europe, Canada, Japan, US, RoW
Darolutamide (BAY1841788, Nubeqa), Placebo matching darolutamide, ADT
Bayer
Biochemically Recurrent Prostate Cancer
07/27
03/30
EvoPAR-PR01, NCT06120491: Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Recruiting
3
1800
Europe, Canada, Japan, US, RoW
Saruparib, AZD5305, Placebo, Abiraterone Acetate, Zytiga, Darolutamide, Nubequa, Enzalutamide, Xtandi
AstraZeneca
Metastatic Castration-Sensitive Prostate Cancer
01/28
04/31
DASL-HiCaP, NCT04136353: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Active, not recruiting
3
1100
Europe, Canada, US, RoW
Darolutamide, Placebo oral tablet, Luteinizing Hormone-Releasing Hormone Analog, External Beam Radiotherapy
University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, Cancer Trials Ireland, Canadian Cancer Trials Group, Memorial Sloan Kettering Cancer Center, Prostate Cancer Clinical Trials Consortium
Prostate Cancer
01/28
07/28
PEACE6-Unfit, NCT04916613 / 2020-003663-26: ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

Recruiting
3
300
Europe
Darolutamide 300 mg, Nubeqa®, Placebo, Androgen deprivation therapy, ADT
UNICANCER, Bayer
Prostate Cancer Metastatic
03/28
09/37
ERADICATE, NCT04484818: Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The Study

Active, not recruiting
3
27
US
Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, ODM 201, ODM-201, Goserelin Acetate, ZDX, Zoladex, Leuprolide Acetate, A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur, Placebo Administration, Quality-of-Life Assessment, Quality of Life Assessment, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532, Detryptoreline
ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
Prostate Carcinoma
12/25
05/28
CARE, NCT05771896: Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

Withdrawn
3
514
NA
Darolutamide, Nubeqa, Radium-223, Xofigo
GenesisCare USA, Bayer
Metastatic Prostate Cancer
12/28
04/29
A Phase III study comparing darolutamide plus ADT versus placebo plus ADT in high-risk BCR patients, ChiCTR2400082864:

Not yet recruiting
3
750
 
Placebo plus ADT; Darolutamide plus ADT
Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, Bayer Consumer Care AG
Hormone-sensitive prostate cancer is at high risk for biochemical recurrence
 
 
GUIDANCE, NCT05050084: Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Recruiting
3
2050
Canada, US
Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Buserelin, 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig), BSRL, Busereline, Etilamide, HOE 766, HOE-766, HOE766, ICI 123215, ICI-123215, ICI123215, S74 6766, S74-6766, S746766, Tiloryth, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Degarelix, ASP 3550, ASP-3550, ASP3550, FE 200486, FE-200486, FE200486, Firmagon, Flutamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, Sch 13521, Tafenil, Tecnoflut, Testotard, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY 25650, AY-25650, AY25650, CL 118532, CL-118,532, CL-118532, CL118532, Detryptoreline
NRG Oncology, National Cancer Institute (NCI)
Prostate Adenocarcinoma
11/26
11/26
THUNDER, NCT06282588: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Recruiting
2/3
493
Europe
Darolutamide, Nubeqa, BAY1841788, Darolutamide matched placebo, BAY1841788 matched placebo, Radiotherapy, Zoladex 3.6Mg Implant, Goserelin acetate 3.6 mg, Zoladex LA, Goserelin acetate 10.8 mg, Decapeptyl sustained release 22.5 mg, Triptorelin 11.25 mg, Decapeptyl sustained release 11.25 mg, Depo-Eligard 45 mg, Leuprorelin acetate 45 mg, Depo-Eligard 22.5 mg, Leuprorelin acetate 22.5 mg, Depo-Eligard 7.5 mg, Leuprorelin acetate 7.5 mg, Firmagon 120 MG Injection, Degarelix 40 mg, Firmagon 80 MG Injection, Degarelix 20 mg, Docetaxel, Taxotere
Cancer Research Antwerp, Bayer, Veracyte, Inc.
Prostate Cancer
07/30
12/30
ACTRN12623000160639: A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT)

Not yet recruiting
2
32
 
St Vincent's Hospital Sydney, St Vincent's Hospital Sydney
Prostate cancer
 
 
ACTRN12624001458527: A study of opaganib in addition to darolutamide in participants with metastatic hormone resistant prostate cancer, selected for the presence of a specific biomarker.

Not yet recruiting
2
60
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Ramsay Foundation , Bayer Australia Limited
Prostate Cancer
 
 
ACTRN12624000582550: Evaluating the efficacy of bipolar androgen therapy in extending metastasis-free survival in patients with M0 castrate-resistant prostate cancer with prostate specific antigen progression but not radiological or clinical progression on darolutamide.

Recruiting
2
69
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer
Prostate Cancer
 
 
2019-004952-13: Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART)

Not yet recruiting
2
140
Europe
ODM-201, BAY1841788, Film-coated tablet, NUBEQA
University Hospital Ghent, Bayer Consumer Care AG
- Prostate cancer patients with a biochemical recurrence following primary therapy- Hormone-sensitive- Up to 5 metastases on PSMA PET-CT, Prostate Cancer, Diseases [C] - Cancer [C04]
 
 
SAKK 08/16, NCT02933801 / 2016-003996-23: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.

Terminated
2
92
Europe
ODM-201, BAY-1841788, Placebo
Swiss Group for Clinical Cancer Research
Prostate Cancer Metastatic, Prostate Cancer
06/21
11/23
2020-000823-38: Study on the interaction between cabazitaxel and darolutamide in patients with metastatic prostate cancer Studie naar de wisselwerking tussen cabazitaxel en darolutamide bij patiënten met uitgezaaide prostaatkanker

Not yet recruiting
2
17
Europe
Tablet, Infusion, darolutamide, Cabazitaxel
Erasmus MC Cancer Institute, Erasmus MC Cancer Institute
metastatic castration-resistant prostate cancer Gemetastaseerde castratie-resistente prostaatkanker, Prostate cancer spread to other parts of the body Uitgezaaide prostaatkanker, Diseases [C] - Cancer [C04]
 
 
ODENZA, NCT03314324 / 2017-001606-14: A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer

Completed
2
250
Europe
ODM-201, Enzalutamide
Gustave Roussy, Cancer Campus, Grand Paris
Metastatic Castrate-resistant Prostate (CRPC) Cancer
01/22
09/24
2022-002431-53: A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER DAROLUTAMIDE (ODM-201) CONCOMITANT A LA RADIOTHERAPIE CHEZ LES PATIENTS PRESENTANT UN CANCER DE LA PROSTATE A RISQUE INTERMEDIAIRE DEFAVORABLE : UNE ETUDE MULTICENTRIQUE RANDOMISEE NON-COMPARATIVE DE PHASE II

Ongoing
2
62
Europe
DAROLUTAMIDE, Dégarélix, Goséréline, Leuproréline, Triptoréline, RADIOTHERAPY, Tablet, Powder and solvent for solution for injection, Implant in pre-filled syringe, , NUBEQA, FIRMAGON, ZOLADEX, ELIGARD, ENANTONE, DECAPEPTYL, GONAPEPTYL, RADIOTHERAPY
Institut Bergonié, Bayer Healthcare SAS
Prostate cancer Cancer de la prostate, Intermediate unfavorable risk prostate cancer Cancer de la prostate à risque intermédiaire défavorable, Diseases [C] - Cancer [C04]
 
 
NCT05249712: Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

Recruiting
2
30
RoW
Darolutamide 300 mg, Nubeqa, BAY1841788, Androgen deprivation therapy, ADT
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Soochow University
Prostate Cancer
01/23
12/25
2022-003792-41: Chemotherapy with or without darolutamide in men with metastatic prostate cancer.

Not yet recruiting
2
245
Europe
Nubeqa, Tablet, Nubeqa/Darolutamide
Erasmus MC, Bayer
metastatic castration-resistant prostate cancer, Prostate cancer spread to other parts of the body, Diseases [C] - Cancer [C04]
 
 
NCT06173362: Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Recruiting
2
75
US
Abiraterone, CB 7598, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Mamta Parikh, National Cancer Institute (NCI)
Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
11/26
05/27
EORTC-1532, NCT02972060 / 2016-004334-17: ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

Active, not recruiting
2
61
Europe
ODM-201, ADT
European Organisation for Research and Treatment of Cancer - EORTC, Bayer
Prostate Cancer
01/23
12/36
NCT03385655: Prostate Cancer Biomarker Enrichment and Treatment Selection

Active, not recruiting
2
200
Canada
Adavosertib, Savolitinib, Darolutamide, CFI-400945, Ipatasertib, Durvalumab and Tremelimumab, Carboplatin
Canadian Cancer Trials Group, Canadian Cancer Clinical Trials Network, BC Cancer Foundation
Prostate Cancer
06/25
12/25
NRG-GY033, NCT06169124: Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

Active, not recruiting
2
37
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Chest Radiography, Chest X-ray, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Exemestane, Aromasin, FCE-24304, Leuprolide Acetate, A 43818, A-43818, A43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Fensolvi, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Luprodex Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP 144, TAP-144, TAP144, Trenantone, Uno-Enantone, Viadur, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
National Cancer Institute (NCI), NRG Oncology
Adult Ovarian Granulosa Cell Tumor
05/27
05/27
NCT06575257: Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

Recruiting
2
80
RoW
Darolutamide, Goserelin 3.6 mg
Xijing Hospital
Prostate Cancer
05/26
05/29
ExBAT, NCT04558866: Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer ( Trial)

Active, not recruiting
2
51
RoW
Testosterone Cypionate, Deposteron, Darolutamide, Nubeqa
Latin American Cooperative Oncology Group, Bayer
Prostate Cancer
03/24
06/25
DIVINE, NCT06378866: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, Trial

Recruiting
2
220
US
Abiraterone, Abiraterone acetate, CB-7598, CB7598, Zytiga, Apalutamide, ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography (CAT), Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, Degarelix, ASP3550, FE200486, Firmagon, Enzalutamide, ASP9785, MDV3100, Xtandi, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, Nuclear Magnetic Resonance (NMR) Imaging, NMRI, Nuclear Magnetic Resonance Imaging (NMRI), sMRI, Structural MRI (sMRI), NMR Imaging, Patient Observation, Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography (PET), Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, Stereotactic Body Radiation Therapy, SABR, SBRT, Stereotactic Ablative Body Radiation (SABR), Stereotactic Ablative Body Radiation Therapy, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, AY25650, CL-118,532, CL118532, Detryptoreline
Mayo Clinic
Recurrent Castration-Sensitive Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8, Recurrent Prostate Cancer, Castration-resistant Prostate Cancer
05/29
05/29
ARASEC, NCT05059236: A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

Active, not recruiting
2
223
US
Darolutamide (BAY1841788, Nubeqa), ADT
Bayer
Metastatic Hormone-sensitive Prostate Cancer
05/25
06/26
DISCOVARY, NCT05694819: Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma

Active, not recruiting
2
56
Japan
Darolutamide, Goserelin
National Cancer Center Hospital East, Bayer Yakuhin, Ltd.
Salivary Gland Cancer
08/24
03/26
ARACOG, NCT04335682: Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide

Active, not recruiting
2
111
US
Darolutamide, Nubeqa, Enzalutamide, Xtandi
Alliance Foundation Trials, LLC., Bayer
Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer
10/25
08/26
WOMBAT, NCT06594926: Working Out M0 Bipolar Androgen Therapy

Recruiting
2
69
RoW
Testosterone Enanthate, Primoteston Depot
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, The George Institute, HMRI
Prostate Cancer
12/26
12/28
ARAMON, NCT05526248: A Study Called to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide

Completed
2
65
US
Darolutamide(BAY1841788, Nubeqa), Enzalutamide
Bayer
Biochemically Recurrent Prostate Cancer
08/24
12/24
SAKK 08/23, NCT06401980: Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Recruiting
2
162
Europe
Darolutamide, Nubeqa®, Standard of care
Swiss Group for Clinical Cancer Research
Metastatic Castration-resistant Prostate Cancer
09/29
12/29
NCT05171387: Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate Cancer

Completed
2
78
RoW
Darolutamide 600 mg twice daily, Androgen deprivation therapy (ADT)
Bayer
Prostate Cancer
12/24
02/25
PICASSO, NCT04925648: Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction

Recruiting
2
22
RoW
Dasatinib, Darolutamide
St Vincent's Hospital, Sydney
Metastatic Prostate Cancer
09/25
12/25
NCT06463457: Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Active, not recruiting
2
33
US
Darolutamide, ODM-201, Bay 1841788, C19H19CIN6O2, Relugolix, Orgovyx, RVT-601, TAK-385, 1-[4-[1-[(2,6-difluorophenyl)methyl]-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxothieno[2,3-d]pyrimidin-6-yl]phenyl]-3-methoxyurea, C29H27F2N7O5S
Atish Choudhury, MD, Bayer, Pfizer, National Comprehensive Cancer Network, Sumitomo Pharmaceuticals America
Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer
11/28
11/28
NCT06734130: Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

Recruiting
2
25
US
Luteinizing Hormone-Releasing Hormone (LHRH) analog, Degarelix, Leuprolide, Triptorelin, Relugolix, Androgen Receptor Signal Inhibitor (ARSI), Enzalutamide, Apalutamide, Darolutamide, Docetaxel
H. Lee Moffitt Cancer Center and Research Institute
Metastatic Castration Sensitive Prostate Cancer
01/27
01/27
NCT04025372: INTREPId (INTermediate Risk Erection PreservatIon Trial)

Active, not recruiting
2
234
US
Bicalutamide, GnRH Agonist, Radiation Therapy, Darolutamide
Dana-Farber Cancer Institute, Bayer, Decipher Biosciences
Prostate Cancer
10/27
03/28
Daro-PET, NCT05900973: A Phase 2 Trial of Darolutamide as a Prostate-Specific Membrane Antigen (PSMA) Expression Enhancer in Patients With Localized Prostate Cancer

Recruiting
2
19
RoW
Darolutamide Oral Tablet [Nubeqa]
D'Or Institute for Research and Education, Bayer, RPH Central Pharma
Prostate Cancer
05/25
05/25
NCT07027124: Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer

Not yet recruiting
2
40
US
Darolutamide, Nubeqa, Pembrolizumab, Keytruda, Lupron, Leuprolide
Icahn School of Medicine at Mount Sinai, Merck Sharp & Dohme LLC, Bayer
Prostate Cancer, High-risk Prostate Cancer
12/26
05/31
NCT06029036: A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer

Recruiting
2
53
RoW
Darolutamide+ADT
Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xijing Hospital of Air Force Military Medical University
Prostate Cancer
07/25
07/26
DARIUS, NCT05346848 / 2022-002431-53: Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

Recruiting
2
62
Europe
Association of darolutamide and EBRT, Association of ADT and EBRT
Institut Bergonié, Bayer
Prostate Cancer
08/25
02/30
NCT07016399: Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC

Not yet recruiting
2
51
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Breast Biopsy Procedure, Breast Biopsy, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Epirubicin, 4'-epi DX, 4'-Epiadriamycin, 4'-Epidoxorubicin, Epi DX, Epidoxorubicin, Pidorubicin, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Pembrolizumab, BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475, Surgical Procedure, Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery, Ultrasound Imaging, 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US
Vandana Abramson, National Cancer Institute (NCI)
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
09/28
10/33
DART, NCT04641078: Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer

Recruiting
2
124
Europe
Darolutamide, metastasis-directed treatment
University Hospital, Ghent
Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic Cancer, Oligometastasis
02/26
02/26
DECREASE, NCT04319783: Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

Recruiting
2
70
RoW
Darolutamide, NUBEQA, Bayer HealthCare Pharmaceuticals Inc., Radiotherapy
Trans Tasman Radiation Oncology Group, Bayer, Peter MacCallum Cancer Centre, Australia
Advanced Prostate Carcinoma, Cancer of Prostate, PSA, Castrate Resistant Prostate Cancer
06/26
06/26
ChiCTR2500096436: Efficacy analysis of darolutamide combination therapy in patients with locally advanced or oligometastatic hormone-sensitive prostate cancer

Not yet recruiting
2
60
 
Patients with locally advanced hormone-sensitive prostate cancer receive oral darolutamide at a dose of 600 mg twice daily in combination with androgen deprivation therapy (ADT). Patients with oligometastatic hormone-sensitive prostate cancer receive the same regimen of oral darolutamide 600 mg twice daily combined with ADT, along with transcatheter arterial docetaxel chemotherapy (at a dose of 45 mg/m2 every 3 weeks for a total of 4 cycles). Radical prostatectomy with or without extended pelvic lymph node dissection is performed after 3 months of this treatment.
The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Guangzhou Medical University, researcher self-funded
prostate cancer
 
 
NCT05669664: Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers

Recruiting
2
21
US
Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Leuprolide Acetate, A 43818, A-43818, A43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Fensolvi, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Luprodex Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP 144, TAP-144, TAP144, Trenantone, Uno-Enantone, Viadur, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
National Cancer Institute (NCI)
Locally Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Unresectable Salivary Gland Carcinoma
04/27
04/27
DAROTAXEL, NCT05762536: Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC

Recruiting
2
245
Europe
Darolutamide, Docetaxel or cabazitaxel
Erasmus Medical Center
Metastatic Castration-resistant Prostate Cancer
05/27
05/28
ChiCTR2500096519: Efficacy and Safety Analysis of Darolutamide Combined with Transarterial Docetaxel Infusion Chemotherapy in Patients with Metastatic Hormone-Sensitive Prostate Cancer

Not yet recruiting
2
50
 
Darusartan 600 mg orally twice a day combined with ADT treatment, and doxorubicin perfusion chemotherapy of the prostate artery (45 mg/m2, 3 weeks once, a total of 6 cycles) within one week after starting medication.
The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Guangzhou Medical University, researcher self-funded
prostate cancer
 
 
NCT04070209: Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)

Recruiting
2
66
Canada
Darolutamide (BAY1841788), ODM-201, SBRT
Sir Mortimer B. Davis - Jewish General Hospital
Metastatic Prostate Cancer, Castration-resistant Prostate Cancer
11/27
11/27
SChLAP/IDC, NCT04176081: Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

Not yet recruiting
2
208
Canada
Darolutamide, Nubeqa, ODM-201, Degarelix, Firmagon, Radiation Therapy
University Health Network, Toronto, Prostate Cancer Canada, Bayer
Prostate Cancer
12/28
12/28
ChiCTR2400083776: A two-center, Phase II, randomized controlled study evaluating local radiotherapy with or without pelvic preventive radiotherapy in patients with 1-3 sites of oligo-metastatic prostate cancer (PROLONG-2).

Not yet recruiting
2
126
 
Prophylactic irradiation of the regional lymphatic drainage area + Radiotherapy to the prostate and metastatic lesions group (PRT)+ADT+Darolutamide; Radiotherapy to the prostate and metastatic lesions group (PRT)+ADT+Darolutamide
Peking University First Hospital; Beijing Hospital, Self-funded
prostatic cancer
 
 
SUGAR, NCT05826509: SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer

Recruiting
2
240
Europe
Surgery alone, Peri-operative darolutamide + surgery.
Institut Claudius Regaud, Bayer
Prostate Cancer
05/30
05/30
2021-006289-19: A study to assess safety, efficacy and pharmacokinetics of AZD5305 when given in combination with new hormonal agents in patients with Metastatic Prostate Cancer Studio per valutare sicurezza, efficacia e farmacocinetica di AZD5305 quando somministrato in combinazione con nuovi agenti ormonali in pazienti con carcinoma prostatico metastatico

Not yet recruiting
1/2
140
Europe
Darolutamide, Abiraterone Acetate, -, Enzalutamide, [-], [AZD5305], Film-coated tablet, Capsule, soft, Nubeqa 300 mg compresse rivestite con film, Zytiga, Xtandi
ASTRAZENECA AB, AstraZeneca AB
Metastatic Prostate Cancer Carcinoma prostatico metastatico, Cancer of prostate gland that spreads to different parts of body (metastatic) in men Cancro della ghiandola prostatica che si diffonde in diverse parti del corpo (metastatico) negli uomini, Diseases [C] - Cancer [C04]
 
 
CELC-G-201, NCT06190899: Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting
1/2
54
Europe, US
Gedatolisib, Darolutamide, NUBEQA
Celcuity Inc
mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male, Urogenital Diseases, Male, Prostatic Disease, Prostatic Neoplasms, Castration-Resistant, Prostate Cancer
11/25
11/27
NCT03568656 / 2018-000285-10: Study to Evaluate CCS1477 in Advanced Tumours

Active, not recruiting
1/2
350
Europe, US
CCS1477, Abiraterone acetate, Enzalutamide, Darolutamide, Olaparib, Atezolizumab
CellCentric Ltd.
Metastatic Castration-Resistant Prostate Cancer, Metastatic Breast Cancer, Non-small Cell Lung Cancer, Advanced Solid Tumors
08/25
08/25
NCT05617885: Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

Active, not recruiting
1/2
9
US
Darolutamide, Nubeqa, Abemaciclib, Verzenio, GNRH-A Leuprolide Acetate, Eligard, Lupron Depot, Lupron Depot-Ped, GNRH-A Goserelin, Zoladex, Degarelix, Firmagon
Praful Ravi, MB BCHir, MRCP, Eli Lilly and Company, Bayer
Metastatic Prostate Cancer, Non-metastatic Prostate Cancer, Prostate Cancer
07/25
06/26
CURATE, NCT05272709: TT-702 in Patients With Advanced Solid Tumours.

Recruiting
1/2
188
Europe
TT-702, Darolutamide
Cancer Research UK, Teon Therapeutics, Inc.
Advanced Solid Tumors
06/27
06/27
PETRANHA, NCT05367440 / 2021-006289-19: Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer

Jan 2024 - Dec 2024: Data from PETRANHA trial for metastatic prostate cancer
Recruiting
1/2
190
Europe, US, RoW
AZD5305, Enzalutamide, Xtandi, Abiraterone Acetate, Zytiga, Darolutamide, Nubeqa, Apalutamide, Erleada
AstraZeneca, Bayer
Metastatic Prostate Cancer
04/31
04/31
NCT03724747: Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer

Completed
1
63
Europe, US
BAY2315497 Injection, Darolutamide(BAY1841788)
Bayer
Metastatic Castration Resistant Prostate Cancer (mCRPC)
08/22
10/24
ORIC-944-01, NCT05413421: Study of ORIC-944 in Patients with Metastatic Prostate Cancer

Recruiting
1
250
Europe, US, RoW
ORIC-944, Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets, Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
ORIC Pharmaceuticals
Metastatic Prostate Cancer
12/25
09/26
ENGAGER-PSMA-01, NCT05519449: Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Recruiting
1
272
US, RoW
JANX007, Darolutamide
Janux Therapeutics
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer
07/27
12/28
NCT05683964: Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Recruiting
1
15
US
Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi], Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
09/25
02/26
NCT06631521: Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Recruiting
1
30
US
Darolutamide, Nubeqa, BAY 1841788, Relugolix, Radical Prostatectomy
AdventHealth, Bayer, Sumitomo Pharma Switzerland
Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
06/26
06/26
NCT05999968: Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

Active, not recruiting
1
10
Europe, US
Abemaciclib, LY2835219, Darolutamide, LHRH agonist/antagonist
Eli Lilly and Company, Bayer
Prostatic Neoplasms
02/24
07/26
ASCERTAIN, NCT05938270: A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

Recruiting
1
120
Europe, Canada, US, RoW
Saruparib (AZD5305), Darolutamide is also known as Nubeqa, Darolutamide, No Treatment
AstraZeneca
Prostate Cancer
02/26
02/26
SMMART, NCT03878524: Serial Measurements of Molecular and Architectural Responses to Therapy () PRIME Trial

Terminated
1
2
US
Abemaciclib, LY-2835219, LY2835219, Verzenio, Abiraterone, CB 7598, Afatinib, BIBW 2992, BIBW2992, Bevacizumab, ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev, Anti-VEGF Monoclonal Antibody SIBP04, SIBP 04, SIBP-04, SIBP04, Bicalutamide, Casodex, Cosudex, ICI 176,334, ICI 176334, Biospecimen Collection, Biological Sample Collection, Specimen Collection, Bortezomib, [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade, Cabazitaxel, Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258, Cabozantinib, Capecitabine, Ro 09-1978/000, Xeloda, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Celecoxib, Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177, Cobimetinib, Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, 934660-93-2, Copanlisib, BAY 80-6946, PI3K Inhibitor BAY 80-6946, Dabrafenib, BRAF Inhibitor GSK2118436, GSK-2118436, GSK-2118436A, GSK2118436, Dacomitinib, EGFR Inhibitor PF-00299804, PF-00299804, PF-00299804-03, PF-299804, Vizimpro, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, 1297538-32-9, Dasatinib, BMS-354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, 1428935-60-7, Enasidenib, AG-221, CC-90007 Free Base, Entrectinib, Rozlytrek, RXDX 101, RXDX-101, RXDX101, Enzalutamide, ASP9785, MDV3100, Xtandi, Erlotinib, Everolimus, 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress, Fluorouracil, 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Idelalisib, CAL-101, GS 1101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig, Imatinib, Ipilimumab, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy, Lenvatinib, E7080, ER-203492-00, Multi-Kinase Inhibitor E7080, Leucovorin, Folinic acid, Lorlatinib, 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-, Lorbrena, PF-06463922, Losartan, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Nivolumab, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Olaparib, AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281, Oxaliplatin, 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, Panobinostat, Faridak, LBH589, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Pertuzumab, 2C4, 2C4 Antibody, HS627, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, Pertuzumab Biosimilar HS627, rhuMAb2C4, RO4368451, HLX11, Ponatinib, AP-24534, AP24534, Quality-of-Life Assessment, Quality of Life Assessment, Regorafenib, BAY 73-4506, REGORAFENIB ANHYDROUS, Stivarga, Ruxolitinib, INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424, Sirolimus, AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217, Sorafenib, BA4 43 9006, BAY 43-9006, Bay-439006, Sunitinib, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Trastuzumab Emtansine, Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO132365, RO5304020, T-DM1, Trastuzumab-DM1, Trastuzumab-MCC-DM1, Trastuzumab-MCC-DM1 Antibody-Drug Conjugate, Trastuzumab-MCC-DM1 Immunoconjugate, Tretinoin, 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin, Vemurafenib, BRAF (V600E) kinase inhibitor RO5185426, BRAF(V600E) Kinase Inhibitor RO5185426, PLX-4032, PLX4032, RG 7204, RG7204, RO 5185426, Zelboraf, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto, Vismodegib, Erivedge, GDC-0449, Hedgehog Antagonist GDC-0449, Vorinostat, L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
OHSU Knight Cancer Institute, Oregon Health and Science University
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8, Anemia, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Castration-Resistant Prostate Carcinoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Pancreatic Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Primary Myelofibrosis, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Hematologic Malignancy, Recurrent Hodgkin Lymphoma, Recurrent Myelodysplastic Syndrome, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelomonocytic Leukemia, Refractory Hematologic Malignancy, Refractory Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Myelodysplastic Syndrome, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Primary Myelofibrosis, Refractory Small Lymphocytic Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
12/20
12/20
NCT05818683: A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Recruiting
1
176
Europe, US, RoW
JNJ-78278343, Cetrelimab, JNJ-63723283, Cabazitaxel, Docetaxel, Apalutamide, Enzalutamide, Darolutamide, Abiraterone acetate plus prednisone (AAP)
Janssen Research & Development, LLC
Metastatic Castration-resistant Prostate Neoplasms
06/26
09/27
ECHOS, NCT06473259: Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

Recruiting
N/A
3000
Europe
Docetaxel, Apalutamide Oral Tablet, Enzalutamide Oral Tablet, Abiraterone acetate tablets, Darolutamide Oral Tablet, radiotherapy, Triptorelin
Santa Chiara Hospital
Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Tumor
12/26
12/28
DEAR, NCT05362149: An Observational Study, Called , to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings

Completed
N/A
870
US
Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
Bayer
Non-metastatic Castration-resistant Prostate Cancer
06/23
06/23
NCT05202301: A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely

Active, not recruiting
N/A
13779
US
Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
Bayer
Prostate Cancer
07/25
07/25
ARENA, NCT06204302: An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

Completed
N/A
1800
US
Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
Bayer
Non-metastatic Prostate Cancer, Non-metastatic Castration-resistant Prostate Cancer
04/24
04/24
DEAR-EXT, NCT06013475: An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

Completed
N/A
1375
US
Apalutamide, Darolutamide (BAY 1841788), Nubeqa, Enzalutamide
Bayer
Non-metastatic Castration-resistant Prostate Cancer
06/24
10/24
OLIGOMET, NCT06430411: Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: Study

Not yet recruiting
N/A
500
NA
Radical prostatectomy, Prostate irradiation, Surgical metastasectomy, Irradiation of metastases, Abiraterone acetate, Enzalutamide, Darolutamide, Apalutamide, Docetaxel, Lutetium-PSMA, Androgen deprivation treatment
Medical University of Vienna, IRCCS Ospedale San Raffaele, University Hospital of Cologne, St. Antonius Hospital, Istituto Europeo di Oncologia, University Hospital, Udine, Italy, Azienda Ospedaliera San Giovanni Battista, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice, Lund University, Medical University of Warsaw, Ziekenhuis Netwerk Antwerpen (ZNA)
Prostate Cancer Metastatic, Prostate Cancer Metastatic to Bone, Prostate Cancer, Prostate Neoplasm, Oligometastatic Disease, Oligometastasis
01/31
12/31
NCT06435702: Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

Not yet recruiting
N/A
108
RoW
Darolutamide in addition to androgen deprivation therapy, androgen deprivation therapy only
Peking University Third Hospital, Bayer
Prostate Cancer
07/26
12/29
ChiCTR2400083680: A single-center, single-arm, prospective, intervention study of efficacy and safety of Goserellin Acetate and Darolutamide neoadjuvant therapy in men with high-risk prostate cancer before prostatectomy

Completed
N/A
30
 
Darolutamide (Nubeqa), 600mg bid + Goserellin Acetate (Zoladex), 10.8mg q12w
The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University, SRUCO medical and technology communication center
prostate cancer
 
 
BELBEQA, NCT06498921: An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care

Completed
N/A
106
Europe
Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
Bayer
Metastatic Hormone-sensitive Prostate Cancer
09/24
09/24
NCT06334120: An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea

Recruiting
N/A
600
RoW
Darolutamide (Nubeqa, BAY1841788)
Bayer
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
03/26
06/26
HAYATE, NCT06661122: A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer

Recruiting
N/A
100
Japan
Darolutamide (BAY1841788) + docetaxel + ADT
Bayer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Low-volume Metastasis
03/31
08/31
SOGUG-PRINCIS, NCT06724159: Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

Recruiting
N/A
500
Europe
darolutamide, Nivolumab monotherapy, enfortumab vedotin
Spanish Oncology Genito-Urinary Group, MFAR
Genitourinary Cancers
12/27
12/27
PSA-DEEP02, NCT06652607: PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer

Recruiting
N/A
152
Europe
Enzalutamide, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets, Taxotere (docetaxel), Abiraterone acetate + Prednisone or Prednisolone
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prostate Cancer, Metastatic Cancer, Castrate Sensitive Prostate Cancer
11/26
04/28
NCT07031258: Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer

Not yet recruiting
N/A
50
NA
Dose of docetaxel
Nanfang Hospital, Southern Medical University
Metastatic Hormone-sensitive Prostate Cancer, Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)
12/26
06/27
DAROL, NCT04122976: A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

Active, not recruiting
N/A
805
Europe, Canada, Japan, US, RoW
Darolutamide(Nubeqa, BAY1841788)
Bayer
Prostate Cancer
07/26
10/26
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Nubeqa (darolutamide) / Bayer, Orion Corp
NCT05348876: A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

Recruiting
4
50
RoW
Darolutamide (Nubeqa, BAY1841788)
Bayer
Non-metastatic Castration-resistant Prostate Cancer
01/26
01/26
COAction, NCT06627530: COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

Recruiting
4
144
RoW
Darolutamide Oral Tablet, leuprorelin
Brazilian Clinical Research Institute, Bayer
Prostate Cancer
03/26
09/26
NCT06660862: Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.

Not yet recruiting
4
80
US
Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy
University of Chicago
Prostate Cancer
11/29
11/29
ChiCTR2200057479: DAROL: An observational study of darotamine in patients with non-metastatic castration-resistant prostate cancer

Recruiting
4
1000
 
Darolutamide
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Bayer Aktiengesellschaft, Bayer AG
Castration-resistant prostate cancer
 
 
2019-004818-34: A clinical research study to investigate whether the addition of a new medication (darolutamide) to standard treatment is better for improving the outcomes for men with localised prostate cancer compared to standard treatment.

Not yet recruiting
3
1100
Europe
Darolutamide, BAY 1841788 (darolutamide, ODM-201), Film-coated tablet
Cancer Trials Ireland, Bayer, NHMRC Clinical Trials Centre (CTC), University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer (ANZUP)
Clinically localised prostate cancer defined as very high risk, or with very high risk features., Clinically localised prostate cancer defined as very high risk, or with very high risk features., Diseases [C] - Cancer [C04]
 
 
2020-003093-48: A trial to learn how well darolutamide plus androgen deprivation therapy (ADT) works in comparison to placebo plus ADT in men with prostate cancer that has spread to other parts of their body

Not yet recruiting
3
665
Europe
Darolutamide 300mg film-coated tablet, BAY 1841788, Film-coated tablet, NUBEQA
Bayer Consumer Care AG, Bayer Consumer Care AG
Metastatic hormone-sensitive prostate cancer (mHSPC), Metastatic prostate cancer responsive to hormone therapy which works by either stopping the body from making testosterone, or by stopping testosterone from reaching the cancer cells., Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
ARASENS, NCT02799602 / 2015-002590-38: Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Completed
3
1306
Europe, Canada, Japan, US, RoW
BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
Bayer, Orion Corporation, Orion Pharma
Metastatic Hormone-sensitive Prostate Cancer
10/21
04/23
2021-003542-21: Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial evaluating dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases. Etude de phase III randomisée multicentrique contrôlée contre placebo évaluant l’ajout du darolutamide à l’hormonothérapie et à la radiothérapie chez des patients atteints d’un cancer de prostate avec des métastases ganglionnaires pelviennes.

Ongoing
3
152
Europe
DAROLUTAMIDE, NUBEQA, Film-coated tablet, NUBEQA
ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, BAYER
Prostate cancer with pelvic lymph nodes metastases. Cancer de la prostate avec des métastases ganglionnaires pelviennes., Prostate cancer with pelvic lymph nodes metastases. Cancer de la prostate avec des métastases ganglionnaires pelviennes., Diseases [C] - Cancer [C04]
 
 
NCT06177015: Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Recruiting
3
200
RoW
Darolutamide continuous, Darolutamide, Darolutamide intermittent
The First Affiliated Hospital with Nanjing Medical University
Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy
12/25
12/27
ARANOTE, NCT04736199 / 2020-003093-48: Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

Active, not recruiting
3
669
Europe, Canada, RoW
Darolutamide (Nubeqa, BAY1841788), Placebo, Androgen deprivation therapy (ADT)
Bayer, Orion Corporation, Orion Pharma
Prostatic Neoplasms
06/24
01/26
GETUG-AFU 42, NCT06496581: Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

Recruiting
3
500
Europe
177Lu-PMSA-617, Pluvicto®, Standard of Care, ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapy* or ADT with docetaxel* plus an ARSI (i.e abiraterone + prednisone, or darolutamide,) ± radiotherapy
UNICANCER, Novartis
Prostate Cancer Metastatic
02/33
08/39
PEACE8, NCT06276465: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Recruiting
3
336
Europe
Darolutamide 300 mg, Nubeqa, Stereotactic body radiation therapy, SBRT, Androgen deprivation therapy, ADT
UNICANCER, Bayer
Prostatic Cancer, Castration-Resistant
10/29
10/32
ARASAFE, NCT05676203: A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

Active, not recruiting
3
250
Europe
Standard ADT (androgen deprivation therapy), Standard Darolutamide, Docetaxel
Jena University Hospital, Bayer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
07/25
01/27
PEACE 7, NCT06625970: Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

Recruiting
3
700
Europe, RoW
Darolutamide, Stereotactic Body RadioTherapy (SBRT), ADT (Standard of Care), LHRH agonists, LHRH antagonists, radiotherapy, Normo-fractionated radiotherapy, Hypo-fractionated radiotherapy, intensity modulated radiotherapy (IMRT), whole pelvic nodal radiotherapy (WPRT)
UNICANCER, Bayer
High Risk Prostate Carcinoma, Prostate Cancer
10/33
10/45
TRIPLE-SWITCH, NCT06592924: Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Recruiting
3
830
Canada
Abiraterone, Enzalutamide, Apalutamide, Darolutamide (BAY 1841788), Docetaxel, ADT
Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, Alliance for Clinical Trials in Oncology, SWOG Cancer Research Network
Prostate Cancer (Adenocarcinoma)
03/31
04/31
ARAMIS Rollover, NCT04464226 / 2019-003618-15: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Recruiting
3
402
Europe, Canada, Japan, US, RoW
Darolutamide (Nubeqa, BAY1841788), ODM-201
Bayer
Cancer
06/28
06/28
ALADDIN, NCT05116475: Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

Recruiting
3
152
Europe
Darolutamide 300 mg, Placebo of Darolutamide
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie, Bayer
Prostate Cancer
02/26
02/27
ProBio, NCT03903835 / 2018-002350-78: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Recruiting
3
750
Europe
Enzalutamide Oral Capsule, Xtandi, Abiraterone Oral Tablet, Zytiga, Carboplatin, Cabazitaxel 60 mg Solution for Injection, Docetaxel Injectable Solution, Radium Chloride Ra-223, Xofigo, Niraparib plus Abiraterone acetate plus Prednisone, Akeega, Capivasertib plus Docetaxel, Apalutamide, Erleada, Darolutamide, Nubeqa
Karolinska Institutet, The Swedish Research Council, Kom Op Tegen Kanker, Janssen Pharmaceutica N.V., Belgium, AstraZeneca, Cancerfonden
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
12/26
12/26
ARASTEP, NCT05794906: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

Recruiting
3
970
Europe, Canada, Japan, US, RoW
Darolutamide (BAY1841788, Nubeqa), Placebo matching darolutamide, ADT
Bayer
Biochemically Recurrent Prostate Cancer
07/27
03/30
EvoPAR-PR01, NCT06120491: Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Recruiting
3
1800
Europe, Canada, Japan, US, RoW
Saruparib, AZD5305, Placebo, Abiraterone Acetate, Zytiga, Darolutamide, Nubequa, Enzalutamide, Xtandi
AstraZeneca
Metastatic Castration-Sensitive Prostate Cancer
01/28
04/31
DASL-HiCaP, NCT04136353: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Active, not recruiting
3
1100
Europe, Canada, US, RoW
Darolutamide, Placebo oral tablet, Luteinizing Hormone-Releasing Hormone Analog, External Beam Radiotherapy
University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, Cancer Trials Ireland, Canadian Cancer Trials Group, Memorial Sloan Kettering Cancer Center, Prostate Cancer Clinical Trials Consortium
Prostate Cancer
01/28
07/28
PEACE6-Unfit, NCT04916613 / 2020-003663-26: ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

Recruiting
3
300
Europe
Darolutamide 300 mg, Nubeqa®, Placebo, Androgen deprivation therapy, ADT
UNICANCER, Bayer
Prostate Cancer Metastatic
03/28
09/37
ERADICATE, NCT04484818: Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The Study

Active, not recruiting
3
27
US
Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, ODM 201, ODM-201, Goserelin Acetate, ZDX, Zoladex, Leuprolide Acetate, A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur, Placebo Administration, Quality-of-Life Assessment, Quality of Life Assessment, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532, Detryptoreline
ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
Prostate Carcinoma
12/25
05/28
CARE, NCT05771896: Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

Withdrawn
3
514
NA
Darolutamide, Nubeqa, Radium-223, Xofigo
GenesisCare USA, Bayer
Metastatic Prostate Cancer
12/28
04/29
A Phase III study comparing darolutamide plus ADT versus placebo plus ADT in high-risk BCR patients, ChiCTR2400082864:

Not yet recruiting
3
750
 
Placebo plus ADT; Darolutamide plus ADT
Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, Bayer Consumer Care AG
Hormone-sensitive prostate cancer is at high risk for biochemical recurrence
 
 
GUIDANCE, NCT05050084: Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Recruiting
3
2050
Canada, US
Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Buserelin, 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig), BSRL, Busereline, Etilamide, HOE 766, HOE-766, HOE766, ICI 123215, ICI-123215, ICI123215, S74 6766, S74-6766, S746766, Tiloryth, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Degarelix, ASP 3550, ASP-3550, ASP3550, FE 200486, FE-200486, FE200486, Firmagon, Flutamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, Sch 13521, Tafenil, Tecnoflut, Testotard, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY 25650, AY-25650, AY25650, CL 118532, CL-118,532, CL-118532, CL118532, Detryptoreline
NRG Oncology, National Cancer Institute (NCI)
Prostate Adenocarcinoma
11/26
11/26
THUNDER, NCT06282588: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Recruiting
2/3
493
Europe
Darolutamide, Nubeqa, BAY1841788, Darolutamide matched placebo, BAY1841788 matched placebo, Radiotherapy, Zoladex 3.6Mg Implant, Goserelin acetate 3.6 mg, Zoladex LA, Goserelin acetate 10.8 mg, Decapeptyl sustained release 22.5 mg, Triptorelin 11.25 mg, Decapeptyl sustained release 11.25 mg, Depo-Eligard 45 mg, Leuprorelin acetate 45 mg, Depo-Eligard 22.5 mg, Leuprorelin acetate 22.5 mg, Depo-Eligard 7.5 mg, Leuprorelin acetate 7.5 mg, Firmagon 120 MG Injection, Degarelix 40 mg, Firmagon 80 MG Injection, Degarelix 20 mg, Docetaxel, Taxotere
Cancer Research Antwerp, Bayer, Veracyte, Inc.
Prostate Cancer
07/30
12/30
ACTRN12623000160639: A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT)

Not yet recruiting
2
32
 
St Vincent's Hospital Sydney, St Vincent's Hospital Sydney
Prostate cancer
 
 
ACTRN12624001458527: A study of opaganib in addition to darolutamide in participants with metastatic hormone resistant prostate cancer, selected for the presence of a specific biomarker.

Not yet recruiting
2
60
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Ramsay Foundation , Bayer Australia Limited
Prostate Cancer
 
 
ACTRN12624000582550: Evaluating the efficacy of bipolar androgen therapy in extending metastasis-free survival in patients with M0 castrate-resistant prostate cancer with prostate specific antigen progression but not radiological or clinical progression on darolutamide.

Recruiting
2
69
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer
Prostate Cancer
 
 
2019-004952-13: Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART)

Not yet recruiting
2
140
Europe
ODM-201, BAY1841788, Film-coated tablet, NUBEQA
University Hospital Ghent, Bayer Consumer Care AG
- Prostate cancer patients with a biochemical recurrence following primary therapy- Hormone-sensitive- Up to 5 metastases on PSMA PET-CT, Prostate Cancer, Diseases [C] - Cancer [C04]
 
 
SAKK 08/16, NCT02933801 / 2016-003996-23: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.

Terminated
2
92
Europe
ODM-201, BAY-1841788, Placebo
Swiss Group for Clinical Cancer Research
Prostate Cancer Metastatic, Prostate Cancer
06/21
11/23
2020-000823-38: Study on the interaction between cabazitaxel and darolutamide in patients with metastatic prostate cancer Studie naar de wisselwerking tussen cabazitaxel en darolutamide bij patiënten met uitgezaaide prostaatkanker

Not yet recruiting
2
17
Europe
Tablet, Infusion, darolutamide, Cabazitaxel
Erasmus MC Cancer Institute, Erasmus MC Cancer Institute
metastatic castration-resistant prostate cancer Gemetastaseerde castratie-resistente prostaatkanker, Prostate cancer spread to other parts of the body Uitgezaaide prostaatkanker, Diseases [C] - Cancer [C04]
 
 
ODENZA, NCT03314324 / 2017-001606-14: A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer

Completed
2
250
Europe
ODM-201, Enzalutamide
Gustave Roussy, Cancer Campus, Grand Paris
Metastatic Castrate-resistant Prostate (CRPC) Cancer
01/22
09/24
2022-002431-53: A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER DAROLUTAMIDE (ODM-201) CONCOMITANT A LA RADIOTHERAPIE CHEZ LES PATIENTS PRESENTANT UN CANCER DE LA PROSTATE A RISQUE INTERMEDIAIRE DEFAVORABLE : UNE ETUDE MULTICENTRIQUE RANDOMISEE NON-COMPARATIVE DE PHASE II

Ongoing
2
62
Europe
DAROLUTAMIDE, Dégarélix, Goséréline, Leuproréline, Triptoréline, RADIOTHERAPY, Tablet, Powder and solvent for solution for injection, Implant in pre-filled syringe, , NUBEQA, FIRMAGON, ZOLADEX, ELIGARD, ENANTONE, DECAPEPTYL, GONAPEPTYL, RADIOTHERAPY
Institut Bergonié, Bayer Healthcare SAS
Prostate cancer Cancer de la prostate, Intermediate unfavorable risk prostate cancer Cancer de la prostate à risque intermédiaire défavorable, Diseases [C] - Cancer [C04]
 
 
NCT05249712: Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

Recruiting
2
30
RoW
Darolutamide 300 mg, Nubeqa, BAY1841788, Androgen deprivation therapy, ADT
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Soochow University
Prostate Cancer
01/23
12/25
2022-003792-41: Chemotherapy with or without darolutamide in men with metastatic prostate cancer.

Not yet recruiting
2
245
Europe
Nubeqa, Tablet, Nubeqa/Darolutamide
Erasmus MC, Bayer
metastatic castration-resistant prostate cancer, Prostate cancer spread to other parts of the body, Diseases [C] - Cancer [C04]
 
 
NCT06173362: Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Recruiting
2
75
US
Abiraterone, CB 7598, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Mamta Parikh, National Cancer Institute (NCI)
Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
11/26
05/27
EORTC-1532, NCT02972060 / 2016-004334-17: ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

Active, not recruiting
2
61
Europe
ODM-201, ADT
European Organisation for Research and Treatment of Cancer - EORTC, Bayer
Prostate Cancer
01/23
12/36
NCT03385655: Prostate Cancer Biomarker Enrichment and Treatment Selection

Active, not recruiting
2
200
Canada
Adavosertib, Savolitinib, Darolutamide, CFI-400945, Ipatasertib, Durvalumab and Tremelimumab, Carboplatin
Canadian Cancer Trials Group, Canadian Cancer Clinical Trials Network, BC Cancer Foundation
Prostate Cancer
06/25
12/25
NRG-GY033, NCT06169124: Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

Active, not recruiting
2
37
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Chest Radiography, Chest X-ray, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Exemestane, Aromasin, FCE-24304, Leuprolide Acetate, A 43818, A-43818, A43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Fensolvi, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Luprodex Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP 144, TAP-144, TAP144, Trenantone, Uno-Enantone, Viadur, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
National Cancer Institute (NCI), NRG Oncology
Adult Ovarian Granulosa Cell Tumor
05/27
05/27
NCT06575257: Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

Recruiting
2
80
RoW
Darolutamide, Goserelin 3.6 mg
Xijing Hospital
Prostate Cancer
05/26
05/29
ExBAT, NCT04558866: Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer ( Trial)

Active, not recruiting
2
51
RoW
Testosterone Cypionate, Deposteron, Darolutamide, Nubeqa
Latin American Cooperative Oncology Group, Bayer
Prostate Cancer
03/24
06/25
DIVINE, NCT06378866: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, Trial

Recruiting
2
220
US
Abiraterone, Abiraterone acetate, CB-7598, CB7598, Zytiga, Apalutamide, ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography (CAT), Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, Degarelix, ASP3550, FE200486, Firmagon, Enzalutamide, ASP9785, MDV3100, Xtandi, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, Nuclear Magnetic Resonance (NMR) Imaging, NMRI, Nuclear Magnetic Resonance Imaging (NMRI), sMRI, Structural MRI (sMRI), NMR Imaging, Patient Observation, Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography (PET), Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Questionnaire Administration, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, Stereotactic Body Radiation Therapy, SABR, SBRT, Stereotactic Ablative Body Radiation (SABR), Stereotactic Ablative Body Radiation Therapy, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, AY25650, CL-118,532, CL118532, Detryptoreline
Mayo Clinic
Recurrent Castration-Sensitive Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8, Recurrent Prostate Cancer, Castration-resistant Prostate Cancer
05/29
05/29
ARASEC, NCT05059236: A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

Active, not recruiting
2
223
US
Darolutamide (BAY1841788, Nubeqa), ADT
Bayer
Metastatic Hormone-sensitive Prostate Cancer
05/25
06/26
DISCOVARY, NCT05694819: Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma

Active, not recruiting
2
56
Japan
Darolutamide, Goserelin
National Cancer Center Hospital East, Bayer Yakuhin, Ltd.
Salivary Gland Cancer
08/24
03/26
ARACOG, NCT04335682: Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide

Active, not recruiting
2
111
US
Darolutamide, Nubeqa, Enzalutamide, Xtandi
Alliance Foundation Trials, LLC., Bayer
Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer
10/25
08/26
WOMBAT, NCT06594926: Working Out M0 Bipolar Androgen Therapy

Recruiting
2
69
RoW
Testosterone Enanthate, Primoteston Depot
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, The George Institute, HMRI
Prostate Cancer
12/26
12/28
ARAMON, NCT05526248: A Study Called to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide

Completed
2
65
US
Darolutamide(BAY1841788, Nubeqa), Enzalutamide
Bayer
Biochemically Recurrent Prostate Cancer
08/24
12/24
SAKK 08/23, NCT06401980: Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Recruiting
2
162
Europe
Darolutamide, Nubeqa®, Standard of care
Swiss Group for Clinical Cancer Research
Metastatic Castration-resistant Prostate Cancer
09/29
12/29
NCT05171387: Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate Cancer

Completed
2
78
RoW
Darolutamide 600 mg twice daily, Androgen deprivation therapy (ADT)
Bayer
Prostate Cancer
12/24
02/25
PICASSO, NCT04925648: Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction

Recruiting
2
22
RoW
Dasatinib, Darolutamide
St Vincent's Hospital, Sydney
Metastatic Prostate Cancer
09/25
12/25
NCT06463457: Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Active, not recruiting
2
33
US
Darolutamide, ODM-201, Bay 1841788, C19H19CIN6O2, Relugolix, Orgovyx, RVT-601, TAK-385, 1-[4-[1-[(2,6-difluorophenyl)methyl]-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxothieno[2,3-d]pyrimidin-6-yl]phenyl]-3-methoxyurea, C29H27F2N7O5S
Atish Choudhury, MD, Bayer, Pfizer, National Comprehensive Cancer Network, Sumitomo Pharmaceuticals America
Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer
11/28
11/28
NCT06734130: Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

Recruiting
2
25
US
Luteinizing Hormone-Releasing Hormone (LHRH) analog, Degarelix, Leuprolide, Triptorelin, Relugolix, Androgen Receptor Signal Inhibitor (ARSI), Enzalutamide, Apalutamide, Darolutamide, Docetaxel
H. Lee Moffitt Cancer Center and Research Institute
Metastatic Castration Sensitive Prostate Cancer
01/27
01/27
NCT04025372: INTREPId (INTermediate Risk Erection PreservatIon Trial)

Active, not recruiting
2
234
US
Bicalutamide, GnRH Agonist, Radiation Therapy, Darolutamide
Dana-Farber Cancer Institute, Bayer, Decipher Biosciences
Prostate Cancer
10/27
03/28
Daro-PET, NCT05900973: A Phase 2 Trial of Darolutamide as a Prostate-Specific Membrane Antigen (PSMA) Expression Enhancer in Patients With Localized Prostate Cancer

Recruiting
2
19
RoW
Darolutamide Oral Tablet [Nubeqa]
D'Or Institute for Research and Education, Bayer, RPH Central Pharma
Prostate Cancer
05/25
05/25
NCT07027124: Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer

Not yet recruiting
2
40
US
Darolutamide, Nubeqa, Pembrolizumab, Keytruda, Lupron, Leuprolide
Icahn School of Medicine at Mount Sinai, Merck Sharp & Dohme LLC, Bayer
Prostate Cancer, High-risk Prostate Cancer
12/26
05/31
NCT06029036: A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer

Recruiting
2
53
RoW
Darolutamide+ADT
Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xijing Hospital of Air Force Military Medical University
Prostate Cancer
07/25
07/26
DARIUS, NCT05346848 / 2022-002431-53: Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

Recruiting
2
62
Europe
Association of darolutamide and EBRT, Association of ADT and EBRT
Institut Bergonié, Bayer
Prostate Cancer
08/25
02/30
NCT07016399: Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC

Not yet recruiting
2
51
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Breast Biopsy Procedure, Breast Biopsy, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Epirubicin, 4'-epi DX, 4'-Epiadriamycin, 4'-Epidoxorubicin, Epi DX, Epidoxorubicin, Pidorubicin, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Pembrolizumab, BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475, Surgical Procedure, Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery, Ultrasound Imaging, 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US
Vandana Abramson, National Cancer Institute (NCI)
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
09/28
10/33
DART, NCT04641078: Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer

Recruiting
2
124
Europe
Darolutamide, metastasis-directed treatment
University Hospital, Ghent
Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic Cancer, Oligometastasis
02/26
02/26
DECREASE, NCT04319783: Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

Recruiting
2
70
RoW
Darolutamide, NUBEQA, Bayer HealthCare Pharmaceuticals Inc., Radiotherapy
Trans Tasman Radiation Oncology Group, Bayer, Peter MacCallum Cancer Centre, Australia
Advanced Prostate Carcinoma, Cancer of Prostate, PSA, Castrate Resistant Prostate Cancer
06/26
06/26
ChiCTR2500096436: Efficacy analysis of darolutamide combination therapy in patients with locally advanced or oligometastatic hormone-sensitive prostate cancer

Not yet recruiting
2
60
 
Patients with locally advanced hormone-sensitive prostate cancer receive oral darolutamide at a dose of 600 mg twice daily in combination with androgen deprivation therapy (ADT). Patients with oligometastatic hormone-sensitive prostate cancer receive the same regimen of oral darolutamide 600 mg twice daily combined with ADT, along with transcatheter arterial docetaxel chemotherapy (at a dose of 45 mg/m2 every 3 weeks for a total of 4 cycles). Radical prostatectomy with or without extended pelvic lymph node dissection is performed after 3 months of this treatment.
The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Guangzhou Medical University, researcher self-funded
prostate cancer
 
 
NCT05669664: Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers

Recruiting
2
21
US
Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Leuprolide Acetate, A 43818, A-43818, A43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Fensolvi, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Luprodex Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP 144, TAP-144, TAP144, Trenantone, Uno-Enantone, Viadur, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
National Cancer Institute (NCI)
Locally Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Unresectable Salivary Gland Carcinoma
04/27
04/27
DAROTAXEL, NCT05762536: Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC

Recruiting
2
245
Europe
Darolutamide, Docetaxel or cabazitaxel
Erasmus Medical Center
Metastatic Castration-resistant Prostate Cancer
05/27
05/28
ChiCTR2500096519: Efficacy and Safety Analysis of Darolutamide Combined with Transarterial Docetaxel Infusion Chemotherapy in Patients with Metastatic Hormone-Sensitive Prostate Cancer

Not yet recruiting
2
50
 
Darusartan 600 mg orally twice a day combined with ADT treatment, and doxorubicin perfusion chemotherapy of the prostate artery (45 mg/m2, 3 weeks once, a total of 6 cycles) within one week after starting medication.
The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Guangzhou Medical University, researcher self-funded
prostate cancer
 
 
NCT04070209: Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)

Recruiting
2
66
Canada
Darolutamide (BAY1841788), ODM-201, SBRT
Sir Mortimer B. Davis - Jewish General Hospital
Metastatic Prostate Cancer, Castration-resistant Prostate Cancer
11/27
11/27
SChLAP/IDC, NCT04176081: Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

Not yet recruiting
2
208
Canada
Darolutamide, Nubeqa, ODM-201, Degarelix, Firmagon, Radiation Therapy
University Health Network, Toronto, Prostate Cancer Canada, Bayer
Prostate Cancer
12/28
12/28
ChiCTR2400083776: A two-center, Phase II, randomized controlled study evaluating local radiotherapy with or without pelvic preventive radiotherapy in patients with 1-3 sites of oligo-metastatic prostate cancer (PROLONG-2).

Not yet recruiting
2
126
 
Prophylactic irradiation of the regional lymphatic drainage area + Radiotherapy to the prostate and metastatic lesions group (PRT)+ADT+Darolutamide; Radiotherapy to the prostate and metastatic lesions group (PRT)+ADT+Darolutamide
Peking University First Hospital; Beijing Hospital, Self-funded
prostatic cancer
 
 
SUGAR, NCT05826509: SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer

Recruiting
2
240
Europe
Surgery alone, Peri-operative darolutamide + surgery.
Institut Claudius Regaud, Bayer
Prostate Cancer
05/30
05/30
2021-006289-19: A study to assess safety, efficacy and pharmacokinetics of AZD5305 when given in combination with new hormonal agents in patients with Metastatic Prostate Cancer Studio per valutare sicurezza, efficacia e farmacocinetica di AZD5305 quando somministrato in combinazione con nuovi agenti ormonali in pazienti con carcinoma prostatico metastatico

Not yet recruiting
1/2
140
Europe
Darolutamide, Abiraterone Acetate, -, Enzalutamide, [-], [AZD5305], Film-coated tablet, Capsule, soft, Nubeqa 300 mg compresse rivestite con film, Zytiga, Xtandi
ASTRAZENECA AB, AstraZeneca AB
Metastatic Prostate Cancer Carcinoma prostatico metastatico, Cancer of prostate gland that spreads to different parts of body (metastatic) in men Cancro della ghiandola prostatica che si diffonde in diverse parti del corpo (metastatico) negli uomini, Diseases [C] - Cancer [C04]
 
 
CELC-G-201, NCT06190899: Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting
1/2
54
Europe, US
Gedatolisib, Darolutamide, NUBEQA
Celcuity Inc
mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male, Urogenital Diseases, Male, Prostatic Disease, Prostatic Neoplasms, Castration-Resistant, Prostate Cancer
11/25
11/27
NCT03568656 / 2018-000285-10: Study to Evaluate CCS1477 in Advanced Tumours

Active, not recruiting
1/2
350
Europe, US
CCS1477, Abiraterone acetate, Enzalutamide, Darolutamide, Olaparib, Atezolizumab
CellCentric Ltd.
Metastatic Castration-Resistant Prostate Cancer, Metastatic Breast Cancer, Non-small Cell Lung Cancer, Advanced Solid Tumors
08/25
08/25
NCT05617885: Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

Active, not recruiting
1/2
9
US
Darolutamide, Nubeqa, Abemaciclib, Verzenio, GNRH-A Leuprolide Acetate, Eligard, Lupron Depot, Lupron Depot-Ped, GNRH-A Goserelin, Zoladex, Degarelix, Firmagon
Praful Ravi, MB BCHir, MRCP, Eli Lilly and Company, Bayer
Metastatic Prostate Cancer, Non-metastatic Prostate Cancer, Prostate Cancer
07/25
06/26
CURATE, NCT05272709: TT-702 in Patients With Advanced Solid Tumours.

Recruiting
1/2
188
Europe
TT-702, Darolutamide
Cancer Research UK, Teon Therapeutics, Inc.
Advanced Solid Tumors
06/27
06/27
PETRANHA, NCT05367440 / 2021-006289-19: Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer

Jan 2024 - Dec 2024: Data from PETRANHA trial for metastatic prostate cancer
Recruiting
1/2
190
Europe, US, RoW
AZD5305, Enzalutamide, Xtandi, Abiraterone Acetate, Zytiga, Darolutamide, Nubeqa, Apalutamide, Erleada
AstraZeneca, Bayer
Metastatic Prostate Cancer
04/31
04/31
NCT03724747: Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer

Completed
1
63
Europe, US
BAY2315497 Injection, Darolutamide(BAY1841788)
Bayer
Metastatic Castration Resistant Prostate Cancer (mCRPC)
08/22
10/24
ORIC-944-01, NCT05413421: Study of ORIC-944 in Patients with Metastatic Prostate Cancer

Recruiting
1
250
Europe, US, RoW
ORIC-944, Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets, Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
ORIC Pharmaceuticals
Metastatic Prostate Cancer
12/25
09/26
ENGAGER-PSMA-01, NCT05519449: Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Recruiting
1
272
US, RoW
JANX007, Darolutamide
Janux Therapeutics
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer
07/27
12/28
NCT05683964: Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Recruiting
1
15
US
Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi], Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
09/25
02/26
NCT06631521: Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Recruiting
1
30
US
Darolutamide, Nubeqa, BAY 1841788, Relugolix, Radical Prostatectomy
AdventHealth, Bayer, Sumitomo Pharma Switzerland
Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
06/26
06/26
NCT05999968: Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

Active, not recruiting
1
10
Europe, US
Abemaciclib, LY2835219, Darolutamide, LHRH agonist/antagonist
Eli Lilly and Company, Bayer
Prostatic Neoplasms
02/24
07/26
ASCERTAIN, NCT05938270: A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

Recruiting
1
120
Europe, Canada, US, RoW
Saruparib (AZD5305), Darolutamide is also known as Nubeqa, Darolutamide, No Treatment
AstraZeneca
Prostate Cancer
02/26
02/26
SMMART, NCT03878524: Serial Measurements of Molecular and Architectural Responses to Therapy () PRIME Trial

Terminated
1
2
US
Abemaciclib, LY-2835219, LY2835219, Verzenio, Abiraterone, CB 7598, Afatinib, BIBW 2992, BIBW2992, Bevacizumab, ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev, Anti-VEGF Monoclonal Antibody SIBP04, SIBP 04, SIBP-04, SIBP04, Bicalutamide, Casodex, Cosudex, ICI 176,334, ICI 176334, Biospecimen Collection, Biological Sample Collection, Specimen Collection, Bortezomib, [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade, Cabazitaxel, Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258, Cabozantinib, Capecitabine, Ro 09-1978/000, Xeloda, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Celecoxib, Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177, Cobimetinib, Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, 934660-93-2, Copanlisib, BAY 80-6946, PI3K Inhibitor BAY 80-6946, Dabrafenib, BRAF Inhibitor GSK2118436, GSK-2118436, GSK-2118436A, GSK2118436, Dacomitinib, EGFR Inhibitor PF-00299804, PF-00299804, PF-00299804-03, PF-299804, Vizimpro, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, 1297538-32-9, Dasatinib, BMS-354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, 1428935-60-7, Enasidenib, AG-221, CC-90007 Free Base, Entrectinib, Rozlytrek, RXDX 101, RXDX-101, RXDX101, Enzalutamide, ASP9785, MDV3100, Xtandi, Erlotinib, Everolimus, 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress, Fluorouracil, 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Idelalisib, CAL-101, GS 1101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig, Imatinib, Ipilimumab, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy, Lenvatinib, E7080, ER-203492-00, Multi-Kinase Inhibitor E7080, Leucovorin, Folinic acid, Lorlatinib, 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-, Lorbrena, PF-06463922, Losartan, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Nivolumab, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Olaparib, AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281, Oxaliplatin, 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, Panobinostat, Faridak, LBH589, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Pertuzumab, 2C4, 2C4 Antibody, HS627, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, Pertuzumab Biosimilar HS627, rhuMAb2C4, RO4368451, HLX11, Ponatinib, AP-24534, AP24534, Quality-of-Life Assessment, Quality of Life Assessment, Regorafenib, BAY 73-4506, REGORAFENIB ANHYDROUS, Stivarga, Ruxolitinib, INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424, Sirolimus, AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217, Sorafenib, BA4 43 9006, BAY 43-9006, Bay-439006, Sunitinib, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Trastuzumab Emtansine, Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO132365, RO5304020, T-DM1, Trastuzumab-DM1, Trastuzumab-MCC-DM1, Trastuzumab-MCC-DM1 Antibody-Drug Conjugate, Trastuzumab-MCC-DM1 Immunoconjugate, Tretinoin, 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin, Vemurafenib, BRAF (V600E) kinase inhibitor RO5185426, BRAF(V600E) Kinase Inhibitor RO5185426, PLX-4032, PLX4032, RG 7204, RG7204, RO 5185426, Zelboraf, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto, Vismodegib, Erivedge, GDC-0449, Hedgehog Antagonist GDC-0449, Vorinostat, L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
OHSU Knight Cancer Institute, Oregon Health and Science University
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8, Anemia, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Castration-Resistant Prostate Carcinoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Pancreatic Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Primary Myelofibrosis, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Hematologic Malignancy, Recurrent Hodgkin Lymphoma, Recurrent Myelodysplastic Syndrome, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelomonocytic Leukemia, Refractory Hematologic Malignancy, Refractory Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Myelodysplastic Syndrome, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Primary Myelofibrosis, Refractory Small Lymphocytic Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
12/20
12/20
NCT05818683: A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Recruiting
1
176
Europe, US, RoW
JNJ-78278343, Cetrelimab, JNJ-63723283, Cabazitaxel, Docetaxel, Apalutamide, Enzalutamide, Darolutamide, Abiraterone acetate plus prednisone (AAP)
Janssen Research & Development, LLC
Metastatic Castration-resistant Prostate Neoplasms
06/26
09/27
ECHOS, NCT06473259: Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

Recruiting
N/A
3000
Europe
Docetaxel, Apalutamide Oral Tablet, Enzalutamide Oral Tablet, Abiraterone acetate tablets, Darolutamide Oral Tablet, radiotherapy, Triptorelin
Santa Chiara Hospital
Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Tumor
12/26
12/28
DEAR, NCT05362149: An Observational Study, Called , to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings

Completed
N/A
870
US
Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
Bayer
Non-metastatic Castration-resistant Prostate Cancer
06/23
06/23
NCT05202301: A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely

Active, not recruiting
N/A
13779
US
Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
Bayer
Prostate Cancer
07/25
07/25
ARENA, NCT06204302: An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

Completed
N/A
1800
US
Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
Bayer
Non-metastatic Prostate Cancer, Non-metastatic Castration-resistant Prostate Cancer
04/24
04/24
DEAR-EXT, NCT06013475: An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

Completed
N/A
1375
US
Apalutamide, Darolutamide (BAY 1841788), Nubeqa, Enzalutamide
Bayer
Non-metastatic Castration-resistant Prostate Cancer
06/24
10/24
OLIGOMET, NCT06430411: Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: Study

Not yet recruiting
N/A
500
NA
Radical prostatectomy, Prostate irradiation, Surgical metastasectomy, Irradiation of metastases, Abiraterone acetate, Enzalutamide, Darolutamide, Apalutamide, Docetaxel, Lutetium-PSMA, Androgen deprivation treatment
Medical University of Vienna, IRCCS Ospedale San Raffaele, University Hospital of Cologne, St. Antonius Hospital, Istituto Europeo di Oncologia, University Hospital, Udine, Italy, Azienda Ospedaliera San Giovanni Battista, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice, Lund University, Medical University of Warsaw, Ziekenhuis Netwerk Antwerpen (ZNA)
Prostate Cancer Metastatic, Prostate Cancer Metastatic to Bone, Prostate Cancer, Prostate Neoplasm, Oligometastatic Disease, Oligometastasis
01/31
12/31
NCT06435702: Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

Not yet recruiting
N/A
108
RoW
Darolutamide in addition to androgen deprivation therapy, androgen deprivation therapy only
Peking University Third Hospital, Bayer
Prostate Cancer
07/26
12/29
ChiCTR2400083680: A single-center, single-arm, prospective, intervention study of efficacy and safety of Goserellin Acetate and Darolutamide neoadjuvant therapy in men with high-risk prostate cancer before prostatectomy

Completed
N/A
30
 
Darolutamide (Nubeqa), 600mg bid + Goserellin Acetate (Zoladex), 10.8mg q12w
The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University, SRUCO medical and technology communication center
prostate cancer
 
 
BELBEQA, NCT06498921: An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care

Completed
N/A
106
Europe
Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
Bayer
Metastatic Hormone-sensitive Prostate Cancer
09/24
09/24
NCT06334120: An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea

Recruiting
N/A
600
RoW
Darolutamide (Nubeqa, BAY1841788)
Bayer
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
03/26
06/26
HAYATE, NCT06661122: A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer

Recruiting
N/A
100
Japan
Darolutamide (BAY1841788) + docetaxel + ADT
Bayer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Low-volume Metastasis
03/31
08/31
SOGUG-PRINCIS, NCT06724159: Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

Recruiting
N/A
500
Europe
darolutamide, Nivolumab monotherapy, enfortumab vedotin
Spanish Oncology Genito-Urinary Group, MFAR
Genitourinary Cancers
12/27
12/27
PSA-DEEP02, NCT06652607: PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer

Recruiting
N/A
152
Europe
Enzalutamide, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets, Taxotere (docetaxel), Abiraterone acetate + Prednisone or Prednisolone
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prostate Cancer, Metastatic Cancer, Castrate Sensitive Prostate Cancer
11/26
04/28
NCT07031258: Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer

Not yet recruiting
N/A
50
NA
Dose of docetaxel
Nanfang Hospital, Southern Medical University
Metastatic Hormone-sensitive Prostate Cancer, Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)
12/26
06/27
DAROL, NCT04122976: A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

Active, not recruiting
N/A
805
Europe, Canada, Japan, US, RoW
Darolutamide(Nubeqa, BAY1841788)
Bayer
Prostate Cancer
07/26
10/26
 

Download Options