- |||||||||| Erleada (apalutamide) / J&J
Trial completion date, Trial primary completion date: c15-164: AASUR in High Risk Prostate Cancer (clinicaltrials.gov) - Feb 9, 2022 P2, N=64, Active, not recruiting, Trial completion date: May 2022 --> May 2023 | Trial primary completion date: May 2022 --> May 2023
- |||||||||| Enrollment change, Trial completion date, Trial primary completion date: Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis (clinicaltrials.gov) - Feb 9, 2022
P4, N=300, Recruiting, Trial completion date: May 2022 --> May 2023 | Trial primary completion date: May 2022 --> May 2023 N=150 --> 300 | Trial completion date: Feb 2020 --> Feb 2022 | Trial primary completion date: Jan 2019 --> Jan 2022
- |||||||||| progesterone / Generic mfg., leuprorelin depot / Generic mfg.
Endogenous autoimmune progesterone dermatitis: successful suppression and desensitization () - Feb 4, 2022 - Abstract #AAAAI2022AAAAI_1535; The patient underwent biopsy showing neutrophilic dermatosis, equivocal skin testing and positive intramuscular challenge resulting in dermatitis flare, consistent with autoimmune progesterone dermatitis. Initiation of leuprolide injections, followed by progesterone desensitization resulted in improvement of dermatitis and no subsequent flares for several years.
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Pharmaceutical good manufacturing practice: Leuplin production in Japan identifies major international shortcomings. (Pubmed Central) - Feb 3, 2022 In Japan, the production of Leuplin, a key drug for the treatment of prostate cancer and breast cancer, was temporarily suspended in 2020 by the manufacturer. The incident illustrated several significant failings, namely the lack of uniformity in international GMP (Good Manufacturing Practice) regulations, the lack of mechanisms to resolve disputes between PIC/S (Pharmaceutical Inspection Co-operation Scheme) member countries, and the importance of maintaining a stable supply of safe GMP-compliant essential medicines.
- |||||||||| 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, The incident illustrated several significant failings, namely the lack of uniformity in international GMP (Good Manufacturing Practice) regulations, the lack of mechanisms to resolve disputes between PIC/S (Pharmaceutical Inspection Co-operation Scheme) member countries, and the importance of maintaining a stable supply of safe GMP-compliant essential medicines. Suspended --> Recruiting | Trial completion date: Dec 2038 --> Dec 2033
- |||||||||| leuprorelin depot / Generic mfg., abiraterone acetate / Generic mfg., docetaxel / Generic mfg.
Journal, PARP Biomarker: Recent Advances in the Management of Metastatic Prostate Cancer. (Pubmed Central) - Feb 1, 2022 Recently, lutetium-177-prostate-specific membrane antigen-617 with standard of care treatment has shown to improve overall survival in men with advanced-stage prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. These recent approvals, successes, and the ongoing investigation of multiple novel agents are expected to continue to dramatically improve survival outcomes of men with metastatic prostate cancer in the coming years.
- |||||||||| leuprorelin depot / Generic mfg.
Clinical, Journal: What is the optimal timing of intracytoplasmic sperm injection (ICSI) after EGG retrieval? A randomized controlled trial. (Pubmed Central) - Jan 27, 2022 In good prognosis couples, we observed no difference in fertilization or blastulation rates based on timing of ICSI within the currently accepted 2- to 6-h window post-retrieval based on a 34-h trigger. The oocyte appears to have a physiological tolerance for fertilization during this window of time, and variability in the timing of ICSI during this window is unlikely to have an impact on cycle outcome.
- |||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
Trial completion, Metastases: HERO: A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (clinicaltrials.gov) - Jan 18, 2022 P3, N=1134, Completed, Renal biopsy is recommended before commencing treatment. Active, not recruiting --> Completed
- |||||||||| Firmagon (degarelix) / Astellas, Ferring
Clinical, Journal, Real-world evidence: Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment. (Pubmed Central) - Jan 13, 2022 In this emulation of a clinical trial of men with cardiovascular disease undergoing treatment for prostate cancer, degarelix was not associated with a lower risk of cardiovascular events than leuprolide. Comparison of these data with PRONOUNCE trial results, when published, will help enhance our understanding of the appropriate role of using real-world data to emulate clinical trials.
- |||||||||| 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.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Real-world treatment patterns among patients with metastatic castration-resistant prostate cancer (mCRPC) in the US. (In-Person & On Demand | Level 1, West Hall - B12) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_281; With rapidly evolving treatment options in metastatic prostate cancer, these data can help guide estimation of eligible patients for different clinical trials. Further studies are needed to understand the high attrition from 1L to subsequent lines of therapy, the reasons for treatment preference and impact on clinical outcomes with different treatment sequencings.
- |||||||||| Erleada (apalutamide) / J&J, Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Relugolix in combination with abiraterone acetate, apalutamide, or docetaxel in men with advanced prostate cancer (aPC): A phase 1, three-part, open-label, parallel-cohort study. (In-Person & On Demand | Level 1, West Hall - Q7) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_227; P1 A protocol amendment was approved in July 2021 to include Part 2 and Part 3 of the study and to add the 40-wk safety extension treatment period. Screening for Part 2 was initiated in August 2021 and for Part 3 it is expected to initiate in January 2022.
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Membrane translocation and activation of GnRH receptor sensitize prostate cancer cells to radiation. (Pubmed Central) - Jan 5, 2022 The aim of this study was to evaluate the effect of radiation on PCa cells pretreated with leuprolide, alone or in combination with IN3, as radiosensitizers...This effect was enhanced by pretreatment with pharmacoperone IN3. Clinical use of IN3 as a radiosensitizer combined with androgen deprivation therapy to improve survival of patients with PCa remains to be evaluated.
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