- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Erleada (apalutamide) / J&J, Firmagon (degarelix) / Astellas, Ferring
Trial initiation date, Metastases: OMPCa-ENSURE: Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer (clinicaltrials.gov) - Mar 16, 2022 P2, N=160, Recruiting, Final analysis of the PROMISE-GIM6 trial provides reassuring results on the safety of GnRHa use during chemotherapy as a strategy to preserve ovarian function in premenopausal patients with early breast cancer, including those with hormone receptor-positive disease. Initiation date: Jan 2022 --> Apr 2022
- |||||||||| Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim
Precise Analysis of the State HTA Progress in Ukraine: Results of the 1st Year of Implementation and Impact (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_1561; 3 medicines were recommended for listing on the NEML or nomenclature (empagliflozin, tiotropium bromide, triptorelin) and 8 medicines were recommended for MEA, others - not recommended. As a result of the work done in the context of state HTA by full procedure, the total of 14 conclusions with recommendations were developed, 8 medicines were recommended for MEA and 2 medicines (empagliflozin, tiotropium bromide) were listed in the NEML due to CMU Decree №1431 dated 31 December, 2021.
- |||||||||| Firmagon (degarelix) / Astellas, Ferring
Enrollment change: Degarelix in the Treatment of Endometriosis Recurrence (clinicaltrials.gov) - Feb 28, 2022 P3, N=360, Completed, New regime of GnRH agonist luteal support in addition to the standard progestogen support was found to be beneficial in overall IVF outcome. N=100 --> 360
- |||||||||| Rekovelle (follitropin delta) / Ferring
Trial completion, Trial completion date: Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND) (clinicaltrials.gov) - Feb 23, 2022 P3, N=437, Completed, However, after 4 weeks of detraining, these effects diminished but did not disappear. Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Feb 2022
- |||||||||| Trial completion, Trial completion date, Trial primary completion date: Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders (clinicaltrials.gov) - Feb 17, 2022
P3, N=90, Completed, Eventually, the proposed method was used for the extraction and quantification of target therapeutic peptides in plasma and urine samples, and satisfactory relative recoveries were achieved in the range of 90.6-110.3%. Not yet recruiting --> Completed | Trial completion date: Dec 2021 --> Sep 2021 | Trial primary completion date: Sep 2021 --> Mar 2021
- |||||||||| Firmagon (degarelix) / Astellas, Ferring, NN1213 / Novo Nordisk
Enrollment closed, Monotherapy: High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov) - Feb 16, 2022 P1/2, N=163, Active, not recruiting, Not yet recruiting --> Completed | Trial completion date: Dec 2021 --> Sep 2021 | Trial primary completion date: Sep 2021 --> Mar 2021 Suspended --> Active, not recruiting
- |||||||||| Suprefact (buserelin acetate) / Sanofi, Erleada (apalutamide) / J&J, Firmagon (degarelix) / Astellas, Ferring
Enrollment open, Trial completion date: Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial (clinicaltrials.gov) - Feb 3, 2022 P3, N=2478, Recruiting, Suspended --> Active, not recruiting Suspended --> Recruiting | Trial completion date: Dec 2038 --> Dec 2033
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Eligard (leuprolide acetate) / Tolmar, Sanofi, Recordati
Enrollment closed, HEOR, Real-world evidence, Real-world, Metastases: A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer (clinicaltrials.gov) - Feb 2, 2022 P=N/A, N=400, Active, not recruiting, Suspended --> Recruiting | Trial completion date: Dec 2038 --> Dec 2033 Not yet recruiting --> Active, not recruiting
- |||||||||| letrozole / Generic mfg., cisplatin / Generic mfg., paclitaxel / Generic mfg.
Clinical, Journal: GnRHa as a treatment for letrozole-resistant recurrent adult granulosa cell tumors: A case report. (Pubmed Central) - Feb 1, 2022 These results need to be consolidated with a subsequent study performed when these women will have reached their mid-thirties. Hormone therapy may be an alternative to treat recurrent granulosa cell tumors, and gonadotropin-releasing hormone agonists may be a rescue treatment for aromatase inhibitor-resistant cases.
- |||||||||| triptorelin / Generic mfg.
Journal: Silk fibroin double-layer microneedles for the encapsulation and controlled release of triptorelin. (Pubmed Central) - Jan 27, 2022 A linear decreasing relationship was observed between the diffusion coefficient and increased β-sheet content. After administration to rats, SF-MNs exhibited long-term testosterone inhibition and maintained castration levels for ≥7 d. Manipulable mechanical properties and release behavior combined with biocompatibility and biodegradability render SF-MNs as viable long-term transdermal delivery devices for triptorelin.
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Eligard (leuprolide acetate) / Tolmar, Sanofi, Recordati
Trial completion date, Trial primary completion date, HEOR, Real-world evidence, Real-world, Metastases: A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer (clinicaltrials.gov) - Jan 19, 2022 P=N/A, N=400, Not yet recruiting, Not yet recruiting --> Recruiting Trial completion date: Jul 2022 --> Sep 2022 | Trial primary completion date: Jul 2022 --> Sep 2022
- |||||||||| Nubeqa (darolutamide) / Bayer, Orion Corp
Long-term safety of darolutamide in patients with metastatic castration-resistant prostate cancer. (In-Person & On Demand | Level 1, West Hall - N5) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_322; P1, P2 Prior systemic anticancer treatments taken by more than 1 patient were bicalutamide (n = 10); cyproterone (n = 3); and triptorelin and leuprorelin (n = 2 each). Extended darolutamide treatment > 2 years in this small group of patients with mCRPC was generally well tolerated, with safety and tolerability consistent with that previously reported.
- |||||||||| docetaxel / Generic mfg.
Enrollment closed, Trial completion date, Trial initiation date: Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer (clinicaltrials.gov) - Jan 3, 2022 P2, N=75, Active, not recruiting, Statistical analyses at completion of study will give additional results. Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Dec 2023 | Initiation date: Sep 2020 --> Dec 2018
- |||||||||| leuprorelin depot / Generic mfg., bicalutamide / Generic mfg.
Journal: Decreased testosterone recovery after androgen deprivation therapy for prostate cancer. (Pubmed Central) - Dec 16, 2021 Increasing age and duration of ADT therapy are associated with decreased likelihood to recover normal testosterone levels after cessation of therapy. The use of the ADT agent goserelin was also associated with decreased testosterone recovery for unclear reasons.
- |||||||||| triptorelin / Generic mfg.
New trial: Hyperbaric Oxygen in (EUDRACT) - Dec 10, 2021 P=N/A, N=40, Not yet recruiting,
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Eligard (leuprolide acetate) / Tolmar, Sanofi, Recordati
New trial, HEOR, Real-world evidence, Real-world, Metastases: A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer (clinicaltrials.gov) - Dec 7, 2021 P=N/A, N=400, Not yet recruiting,
- |||||||||| norethindrone / Generic mfg.
Review, Journal: Treatments for seizures in catamenial (menstrual-related) epilepsy. (Pubmed Central) - Nov 29, 2021 Our review highlights an overall deficiency in the literature base on the effectiveness of a wide range of other hormonal and non-hormonal interventions currently being used in practice, particularly for those women who do not have regular menses. Further clinical trials are needed in this area.
- |||||||||| Erleada (apalutamide) / J&J
LONG TIME RESPONSE IN NON-METASTATIC CRPC WITH APALUTAMIDE: FIRST CASE IN OUR REGION. () - Nov 20, 2021 - Abstract #PROSCABLADDR2021PROSCA_BLADDR_15; CONCLUSIONS Apalutamide has been a breakthrough in the treatment of prostate cancer in advanced stages of the disease, significantly modifying the prognosis of patients at high risk of metastasis. The use of this treatment in clinical practice has shown surprising results that augur a modification of the indications of the drug for its use in different phases of the disease; as in the high-risk metastatic debut (TITAN Study).
- |||||||||| Rekovelle (follitropin delta) / Ferring
Enrollment closed: Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND) (clinicaltrials.gov) - Nov 16, 2021 P3, N=437, Active, not recruiting, It should be kept in mind that in pediatric PCC patients who develop side effects like cutaneous vasculitis, the treatment may be continued by changing the preparation. Recruiting --> Active, not recruiting
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