abiraterone acetate

P3, N=700, Recruiting, AstraZeneca

P4, N=43, Active, not recruiting, AstraZeneca | Completed --> Active, not recruiting | Trial completion date: Jul 2025 --> Dec 2026

P2, N=532, Recruiting, Mayo Clinic | Trial completion date: May 2029 --> Feb 2031 | Trial primary completion date: May 2029 --> Feb 2031

P1, N=16, Completed, Weill Medical College of Cornell University | Active, not recruiting --> Completed | Trial completion date: Oct 2026 --> Oct 2025

He achieved an excellent response to androgen deprivation therapy (ADT) combined with abiraterone and prednisone, maintaining an undetectable prostate-specific antigen (PSA) level for over 2 years...The patient transitioned to docetaxel plus ADT, resulting in symptomatic improvement and partial radiologic response...Second, standard markers such as PSA and immunohistochemistry may be misleading in atypical presentations. Finally, the case highlights the decisive role of molecular diagnostics, specifically NGS, in identifying tumor origin and preventing misdiagnosis.

Key advances include: (1) In bladder cancer, perioperative durvalumab (NIAGARA) and enfortumab vedotin plus pembrolizumab (KEYNOTE-905/EV-303) set new standards, while HER2-targeted disitamab vedotin plus toripalimab (RC48-C016) improved metastatic survival...(3) In prostate cancer, enzalutamide plus leuprolide improved survival in high-risk biochemical recurrence (EMBARK). Capivasertib plus abiraterone benefited PTEN-deficient metastatic hormone-sensitive disease (CAPItello-281). The PSMAddition trial demonstrated that adding [177Lu]Lu-PSMA-617 to standard therapy significantly improved radiographic PFS in PSMA-positive mHSPC. Docetaxel scheduling was optimized (ARASAFE), and an AI model (STAMPEDE) identified patients for AR inhibitor benefit. Novel agents like saruparib and pasritamig showed promise...The 2025 evidence establishes multiple new standards of care across GU cancers, emphasizing biomarker-driven strategies, immunotherapy integration, novel resistance mechanisms, and treatment optimization. This synthesis provides an evidence-based framework for updating guidelines and highlights the move toward more personalized management, while noting persistent challenges and future research needs.

MAICs showed improved clinical benefit with TALA+ENZA versus OLAP+AAP and NIRA+AAP across multiple mCRPC populations and endpoints. Despite limitations of indirect comparisons, findings support TALA+ENZA as a first-line treatment option for mCRPC.

P1, N=15, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed | Trial completion date: Oct 2037 --> Mar 2026 | Trial primary completion date: Oct 2037 --> Mar 2026

P2, N=140, Recruiting, University of Nebraska | Not yet recruiting --> Recruiting

P=N/A, N=1000, Recruiting, Bayer | Not yet recruiting --> Recruiting

P1, N=400, Recruiting, Synnovation Therapeutics, Inc. | N=200 --> 400 | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Dec 2027

Approximately 1800 participants (550 HRRm; 1250 non-HRRm) are randomized 1:1 to receive either saruparib plus physician's choice of ARPI (abiraterone plus prednisone/prednisolone, darolutamide, or enzalutamide) or placebo plus ARPI. Analyses of rPFS and OS will be conducted within each cohort by stratified log-rank test. Enrollment began in November 2023.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06120491; EU CT number is 2023-504214-30-00.