Phase 2 ASP5541 Abiraterone Decanoate CYP17 Inhibitor in Advanced Prostate Cancer

This open-label multi-cohort trial by Astellas Pharma Global Development evaluates ASP5541, an intramuscular form of abiraterone decanoate (a CYP17 inhibitor), versus standard oral abiraterone acetate with prednisone/prednisolone in adult men with metastatic hormone-sensitive or castration-resistant prostate cancer, including a cohort of Japanese patients. The study aims to assess safety and comparative efficacy in treatment-naive individuals. Oral abiraterone acetate + prednisone is a standard backbone across mHSPC and mCRPC; the depot formulation could improve adherence and PK exposure while maintaining efficacy.