Pluvicto (lutetium Lu 177 vipivotide tetraxetan) / Novartis 
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54 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) / Novartis
NCT06099093: Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan

Recruiting
4
30
US
18F-DCFPyl, [F18]-Piflufolastat, Pylarify, 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]- pentyl}ureido)-pentanedioic acid
Brigham and Women's Hospital, Progenics Pharmaceuticals, Inc.
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Carcinoma
12/24
12/25
NCT05803941: Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

Recruiting
4
700
US
AAA617, lutetium (177Lu) vipivotide tetraxetan, [177Lu]Lu-PSMA-617, 177Lu-PSMA-617
Novartis Pharmaceuticals
Prostate Cancer
07/33
07/33
VISION, NCT03511664 / 2018-000459-41: Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

Checkmark Approved in combination with androgen deprivation therapy for treatment of adult patients with PSMA +ve mCRPC based on VISION trial
Dec 2022 - Dec 2022: Approved in combination with androgen deprivation therapy for treatment of adult patients with PSMA +ve mCRPC based on VISION trial
Checkmark Received positive CHMP opinion for PSMA+ve mCRPC based on VISION study
Oct 2022 - Oct 2022: Received positive CHMP opinion for PSMA+ve mCRPC based on VISION study
Checkmark Post hoc analysis data from VISION trial for PSMA-positive mCRPC
More
Completed
3
831
Europe, Canada, US
177Lu-PSMA-617, Best supportive/best standard of care
Endocyte
Prostate Cancer
01/21
12/23
PSMAfore, NCT04689828 / 2020-003969-19: 177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

Calendar Jan 2025 - Dec 2025: Final analysis data from PSMAfore trial for pretaxane 2L mCRPC
Jul 2023 - Dec 2023: Submission in US for pre-taxane mCRPC
Hourglass Oct 2022 - Mar 2023 : Data from PSMAfore trial for pretaxane 2L mCRPC
Active, not recruiting
3
469
Europe, Canada, US, RoW
177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, Comparator, Best supportive care
Novartis Pharmaceuticals
Prostatic Neoplasms
10/22
09/25
NCT05547386: 68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer

Completed
3
163
US
Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography, Gallium Ga 68 Gozetotide, (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Mayo Clinic
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
12/23
12/23
STAMPEDE2, NCT06320067: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer

Recruiting
3
8000
Europe
Stereotactic Ablative Body Radiotherapy (SABR), Stereotactic body radiotherapy (SBRT), 177Lu-PSMA-617, Lutetium (177Lu) Vipivotide Tetraxetan, AAA617, Pluvicto, Niraparib and Abiraterone Acetate Dual Action Tablet DAT, Nira-AA, CJNJ-67652000-ZZZ, Abiraterone Acetate, Zytiga, Apalutamide, Erleada, JNJ-56021927, Androgen Deprivation Therapy (ADT), Androgen Receptor Signalling Inhibitor (ARSI), Local Radiotherapy, Prednisolone, Docetaxel
University College, London, Cancer Research UK, Novartis, Janssen Pharmaceutica NV
Prostate Cancer Metastatic
04/31
03/34
GETUG-AFU 42, NCT06496581: Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

Not yet 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
PSMAddition, NCT04720157 / 2020-003968-56: An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC

Calendar Jan 2024 - Dec 2024: Primary data from PSMAddition trial for metastatic hormone sensitive prostate cancer
Recruiting
3
1126
Europe, Canada, Japan, US, RoW
177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT
Novartis Pharmaceuticals, Alliance Foundation Trials, LLC., RTOG Foundation, Inc.
Prostatic Neoplasms
07/25
02/26
PSMA-DC, NCT05939414: An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

Recruiting
3
450
Europe, Canada, Japan, US, RoW
AAA617, (177Lu) vipivotide tetraxetan
Novartis Pharmaceuticals
Oligometastatic Prostate Cancer (OMPC)
12/27
07/30
ACTRN12617001590358: TheraP: A randomised phase 2 trial of 177-Lutetium-Prostate Specific Membrane Antigen-617 (177Lu-PSMA617) theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer (ANZUP1603)

Active, not recruiting
2
200
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), Prostate Cancer Foundation Australia, Endocyte, Australian Nuclear Science and Technology Organisation (ANSTO)
Prostate cancer
 
 
LU-PSMA, NCT03454750 / 2016-002732-32: Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC)

Active, not recruiting
2
43
Europe
177Lu-PSMA
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Metastatic Castration Resistant Prostate Cancer, 68Ga-PSMA PET/CT Positive
08/23
08/24
ENZA-p, NCT04419402: Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer

Active, not recruiting
2
162
RoW
Lu-PSMA, 177Lutetium -PSMA 617 also referred to as 177Lu-PSMA, Enzalutamide, Xtandi
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, National Health and Medical Research Council, Clinical Trials Centre, Prostate Cancer Research Alliance, Endocyte, Astellas Pharma Inc
Metastatic Castration-Resistant Prostate Cancer
07/24
01/25
Bullseye, NCT04443062 / 2020-000076-37: Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer

Recruiting
2
58
Europe, RoW
177Lu-PSMA-617
Radboud University Medical Center, Prostaatkankerstichting, Advanced Accelerator Applications
Prostate Cancer
01/24
01/25
LuRM_ACC/2023, NCT06199453: The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients With ACC- an Open, Non-commercial Clinical Trial

Not yet recruiting
2
32
Europe
Lutetium (177Lu) vipivotide tetraxetan, Pluvicto 1 000 MBq/mL
Maria Sklodowska-Curie National Research Institute of Oncology
Adenoid Cystic Carcinoma
11/27
11/27
UpFrontPSMA, NCT04343885: In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

Active, not recruiting
2
130
RoW
177Lu-PSMA-617, 177Lu-PSMA-617 also referred to as 177Lu-PSMA, Docetaxel, Taxotere (trade name)
Peter MacCallum Cancer Centre, Australia, Movember Foundation, Prostate Cancer Research Alliance, United States Department of Defense, Advanced Accelerator Applications, Australia's Nuclear Science and Technology Organisation (ANSTO), Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Australasian Radiopharmaceutical Trials network (ARTnet), Centre for Biostatistics and Clinical Trials (BaCT)
Metastatic Hormone Naive Prostate Cancer
04/24
04/24
NCT06200103: Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Recruiting
2
236
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Clinical Observation, observation, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Computerized Tomography (CT) scan, Gallium Ga 68 Gozetotide, (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68, Lutetium Lu 177 Vipivotide Tetraxetan, 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Questionnaire Administration, Single Photon Emission Computed Tomography, Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Mayo Clinic
Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
12/29
12/29
EVOLUTION, NCT05150236: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC

Active, not recruiting
2
93
RoW
177Lu-PSMA-617, 177Lutetium -PSMA 617 also referred to as 177Lu-PSMA, Ipilimumab, YERVOY, Nivolumab, OPDIVO
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Prostate Cancer Foundation of Australia, Bristol-Myers Squibb, Advanced Accelerator Applications, University of Sydney
Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Prostate Cancer, Neoplasms by Site, Neoplasms, Prostatic Disease
08/24
12/24
PSMA-ADJUVO, NCT06449781: 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer

Not yet recruiting
2
200
NA
Lutetium (177Lu) vipivotide tetraxetan, Pluvicto
Maria Sklodowska-Curie National Research Institute of Oncology
Prostate Cancer
11/30
11/30
CCTG PR21, NCT04663997: 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer

Active, not recruiting
2
200
Canada
177Lu-PSMA-617, Docetaxel
Canadian Cancer Trials Group, Prostate Cancer Canada, Endocyte
Prostate Cancer
12/24
07/25
RE-LuPSMA, NCT06288113: Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, Trial

Recruiting
2
40
US
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, CT, CT Scan, tomography, Gallium Ga 68 Gozetotide, (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68, Lutetium Lu 177 Vipivotide Tetraxetan, 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Questionnaire Administration, Single Photon Emission Computed Tomography, Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Jonsson Comprehensive Cancer Center, Novartis Pharmaceuticals
Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
01/26
01/27
FLEX-MRT, NCT06216249: Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Recruiting
2
90
US
Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Gallium Ga 68 Gozetotide, (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68, Lutetium Lu 177 Vipivotide Tetraxetan, 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, PSMA PET Scan, Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography, Questionnaire Administration, Single Photon Emission Computed Tomography, Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Jonsson Comprehensive Cancer Center
Prostate Carcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
12/27
12/28
NCT06145633: Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer

Recruiting
2
15
US
Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Fludeoxyglucose F-18, 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18, Gallium Ga 68 Gozetotide, (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68, Lutetium Lu 177 Vipivotide Tetraxetan, 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Single Photon Emission Computed Tomography, Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon, Vorinostat, L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
University of Washington, Novartis, Institute for Prostate Cancer Research (IPCR)
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
12/25
12/27
NCT06526299: Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease

Not yet recruiting
2
51
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Scan, Bone Scintigraphy, 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, Lutetium Lu 177 Vipivotide Tetraxetan, 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto, 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, PSMA PET-CT Scan, PET-CT (PSMA), Prostate-specific Membrane Antigen PET-CT, PSMA PET-CT, Questionnaire Administration, Single Photon Emission Computed Tomography, Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
University of Washington, Novartis, Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research Fund
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
12/27
12/27
NCT05658003: A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer

Active, not recruiting
2
60
RoW
[177Lu]Lu-PSMA-617, ARDT, Comparator, [68Ga]Ga-PSMA-11, Best supportive care
Novartis Pharmaceuticals
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
11/24
01/27
NCT06004661: Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function

Recruiting
2
20
Europe
AAA617, Pluvicto, 177Lu-Lu-PSMA-617, 68Ga-PSMA-11
Novartis Pharmaceuticals
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
06/26
07/26
NCT05114746: Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan

Recruiting
2
80
Japan
177Lu-PSMA-617, 68Ga-PSMA-11, Best supportive/best standard of care
Novartis Pharmaceuticals, Eckert & Ziegler Radiopharma GmbH
Prostate Cancer
12/23
04/26
NCT05670106: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC

Active, not recruiting
2
62
RoW
[177Lu]Lu-PSMA-617, Best supportive/best standard of care (BS/BSOC), 68Ga-PSMA-11
Novartis Pharmaceuticals
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
01/26
10/26
NCT05766371: Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer

Recruiting
2
48
US
Pembrolizumab, Keytruda, 177Lu-PSMA-617, Lutetium-177-PSMA-617, (177Lu)-PSMA-617
University of California, San Francisco, Merck Sharp & Dohme LLC, Prostate Cancer Foundation
Castrate Resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer, Prostate Carcinoma
05/27
05/31
NCT06084338: Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Recruiting
2
60
US
stereotactic ablative radiotherapy, SBRT, Pluvicto, Lu177-PSMA, topical testosterone, androgel
VA Office of Research and Development
Prostate Cancer
11/27
12/28
PSMACare, NCT05849298: A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

Recruiting
2
120
Europe, Canada, US, RoW
AAA617, Lutetium [177Lu] vipivotide tetraxetan, 177Lu-PSMA-617, AAA517, 68Ga-PSMA-11, Piflufolastat F 18, ARPI, ADT, Best supportive care
Novartis Pharmaceuticals
Prostatic Neoplasm
10/27
12/28
NCT03042468: Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC

Active, not recruiting
1/2
50
US
177Lu-PSMA-617, 68Ga-PSMA-HBED-CC
Weill Medical College of Cornell University
Prostate Cancer
09/21
12/25
LuTectomy, NCT04430192: Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

Active, not recruiting
1/2
20
RoW
177Lu-PSMA-617, 177Lu-PSMA, [177Lu]Lu-PSMA-617, Lu-PSMA
Peter MacCallum Cancer Centre, Australia, Movember Foundation, Medical Research Future Fund, Endocyte, E.J. Whitten Foundation Prostate Cancer Research Centre
Prostatic Neoplasms
12/22
12/23
NEPI, NCT06388369: Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer

Not yet recruiting
1/2
58
Europe
[177Lu]Lu-PSMA-617, Ipilimumab
University Hospital, Essen, Advanced Accelerator Applications, Bristol-Myers Squibb
Very High Risk Prostate Carcinoma
03/27
09/28
STARLiT, NCT06574880: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

Not yet recruiting
1/2
45
US
Lu-PSMA-617, Pluvicto, 5-fraction Stereotactic Body Radiation Therapy (SBRT), SBRT
Angela Y. Jia, MD PhD
Malignant Neoplasm of Prostate, Locally Advanced Prostate Cancer
09/25
09/26
LUNAAR, NCT06329830: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Withdrawn
1/2
30
US
177Lu-PSMA-617, Pluvicto, Niraparib abiraterone acetate, Akeega, Prednisone, Rayos, Prednisone Intensol, Deltasone
Baptist Health South Florida, Janssen Scientific Affairs, LLC
Metastatic Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
10/26
10/28
UPLIFT, NCT05113537: Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Recruiting
1/2
30
US
Abemaciclib, Abemaciclib Oral, LY-2835219, Verzenio, Lutetium Lu 177-PSMA-617, 177Lu-labeled PSMA-617, Lutetium Lu 177 Vipivotide Tetraxetan
Vadim S Koshkin, Prostate Cancer Foundation, Eli Lilly and Company
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Metastatic Castration-resistant Prostate Carcinoma, Metastatic Castration-resistant Prostate Cancer
12/25
07/27
COMBAT, NCT05633160: 64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617

Recruiting
1/2
38
US
64Cu-SAR-BBN, 67Cu-SAR-BBN
Clarity Pharmaceuticals Ltd
Prostatic Neoplasms, Castration-Resistant
05/26
05/26
LuCAB, NCT05340374: Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer

Recruiting
1/2
44
RoW
Cabazitaxel, 177Lu-PSMA-617
Peter MacCallum Cancer Centre, Australia
Metastatic Castration-resistant Prostate Cancer, mCRPC
06/26
12/26
PRESERVE-006, NCT05682443: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

Recruiting
1/2
144
US
ONC-392, A humanized anti-CTLA4 IgG1 monoclonal antibody, Gotistobart, lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses., Pluvicto
OncoC4, Inc., Prostate Cancer Clinical Trials Consortium
Metastatic Castration-resistant Prostate Cancer
06/26
06/27
LuPARP, NCT03874884: 177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer

Recruiting
1
70
RoW
Olaparib, 177Lu-PSMA
Peter MacCallum Cancer Centre, Australia
Metastatic Castration Resistant Prostate Cancer (mCRPC)
05/25
06/26
PROQURE-1, NCT05162573: EBRT + Lu-PSMA for N1M0 Prostate Cancer

Recruiting
1
24
Europe
177Lu-PSMA-617, EBRT
The Netherlands Cancer Institute, UMC Utrecht, Advanced Accelerator Applications
Prostatic Neoplasm
07/25
07/25
R01CA229354, NCT03805594: 177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting
1
43
US
Lutetium Lu 177-PSMA-617, 177Lu-PSMA-617, Lu177-PSMA-617, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475
University of California, San Francisco, Prostate Cancer Foundation, National Cancer Institute (NCI)
Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer, Stage IVA Prostate Cancer, Stage IVB Prostate Cancer
01/24
04/25
NCT06303713: LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer

Recruiting
1
37
US
Carboplatin, C6H12N2O4Pt, Platinum, diammine [1,1-cyclobutanedicarboxylato(2-)- O,O']-, (SP-4-2), 177Lu-PSMA-617, Pluvicto, Lutetium Lu 177 vipivotide tetraxetan, C49H71N9O16
Dana-Farber Cancer Institute, Novartis
Prostate Cancer, Metastatic Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
07/26
07/26
NCT06379217: NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

Recruiting
1
36
Europe
[68Ga]Ga-PSMA-11, Gallium (68Ga) gozetotide, [68Ga]GA-DOTA-TATE, Gallium (68Ga) DOTA-TATE, [68Ga]Ga-NeoB, Gallium NeoB, [177Lu]Lu-PSMA-617, Lutetium (177Lu) vipivotide tetraxetan, [177Lu]Lu-DOTA-TATE, Lutetium (177Lu) DOTA-TATE, [177Lu]Lu-NeoB, Lutetium NeoB, L-Lysine HCl-L-Arginine HCl, 2.5 %,, Lysine HCl-Arginine HCl, 2.5 %, Gonadotropin-releasing hormone (GnRH) analogues, GnRH antagonists, Antiemetics & antinauseants, Metoclopramide
Novartis Pharmaceuticals
Metastatic Neuroendocrine Prostate Cancer
06/27
06/27
NCT05079698: A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer

Active, not recruiting
1
6
US
177Lu-PSMA-617, Stereotactic Body Radiotherapy (SBRT)
Memorial Sloan Kettering Cancer Center, Novartis Pharmaceuticals
Prostate Cancer
10/25
10/25
NCT06516510: A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer

Not yet recruiting
1
24
NA
lutetium (177Lu) rhPSMA 10.1 and Pluvicto®
Blue Earth Therapeutics Ltd, Medpace, Inc.
Metastatic Prostate Cancer
10/25
01/26
RADIODOSE, NCT06531499: A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation () Study

Not yet recruiting
1
106
NA
AAA617, Lutetium (177Lu) vipivotide tetraxetan, [177Lu]Lu-PSMA-617, Gonadotropin-releasing hormone (GnRH) analogues, Gonadotropin-releasing hormone (GnRH) antagonists
Novartis Pharmaceuticals
Metastatic Castration-Resistant Prostate Cancer
12/27
01/28
CaboLu, NCT05613894: Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer

Recruiting
1
33
US
Cabozantinib, 177Lu-PSMA-617
University of Utah, Exelixis
Metastatic Castration-resistant Prostate Cancer
05/25
05/28
PSMA-617-100, NCT04597411: Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer

Recruiting
1
60
RoW
225^Ac-PSMA-617, 68^Ga-PSMA-11
Endocyte
Prostatic Neoplasms, Castration-Resistant
01/27
01/27
NCT04825652: 177Lu-PSMA-617 Managed Access Program for mCRPC Patients

No Longer Available
N/A
NA
177Lu-PSMA-617, PSMA-11
Advanced Accelerator Applications
Metastatic Castration-resistant Prostate Cancer (mCRPC)
 
 
GaLuPro, NCT06136377: Evaluation of the Concordance Between Pre-therapy Dosimetry Performed From 68Ga-PSMA-11 Dynamic PET and Post-treatment Dosimetry of 177Lu-PSMA-617 Vectorized Internal Radiotherapy in Patients With Metastatic Prostate Cancer Resistant to Hormonal Castration.

Not yet recruiting
N/A
35
NA
177Lu-PSMA-617 PET scan
Centre Georges Francois Leclerc
Patients With Metastatic Castration-resistant Prostate Cancer
01/27
01/27
(SEEtoTREAT), NCT06389097: SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization

Not yet recruiting
N/A
80
NA
Radium-223, 177Lu-DOTATATE, 177Lu-PSMA-617
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, National Cancer Institute (NCI)
Prostate Cancer, Advanced Cancer
08/28
08/29
NCT06514521: Post Marketing Study on Pluvicto in Korea

Not yet recruiting
N/A
278
NA
Lutetium vipivotide tetraxetan, Pluvicto
Novartis Pharmaceuticals
Metastatic Castration-resistant Prostate Cancer
07/27
07/27
PROLUT, NCT06461689: Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer

Not yet recruiting
N/A
80
Europe
177Lu-PSMA-617
Central Hospital, Nancy, France
Prostate Cancer Metastatic
09/25
03/26

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