Phase 3 Study Comparing Opevesostat to Abiraterone Acetate or Enzalutamide in Men With Advanced Metastatic Castration-Resistant Prostate Cancer Previously Treated With Hormonal Therapy and Chemotherapy

What this Trial Is About

Researchers are evaluating the drug opevesostat in a phase 3, randomized, open-label study for men with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with next-generation hormonal agents and taxane-based chemotherapy. The study aims to compare overall survival between participants receiving opevesostat and those receiving alternative treatments, including abiraterone acetate or enzalutamide. The research focuses on participants with specific androgen receptor mutations to determine if opevesostat provides better outcomes. Participants are assigned to one of two groups one group receives opevesostat 5 mg orally twice daily along with dexamethasone and fludrocortisone acetate daily, with hydrocortisone available as rescue medication. The other group receives either abiraterone acetate 1000 mg daily plus prednisone 5 mg twice daily or enzalutamide 160 mg daily. Treatments continue until disease progression, with prior prednisone use replaced by hydrocortisone in later protocol versions. During the study, participants undergo regular assessments including scans and laboratory tests to monitor prostate cancer progression and treatment effects. Researchers measure overall survival and several secondary outcomes such as progression-free survival, response duration, pain progression, and adverse events for up to approximately 54 months. The study also tracks safety and treatment discontinuation, with ongoing evaluations throughout the treatment period and follow-up.

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)