MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)

Nature and Objective:
This Phase 3 study evaluates the efficacy and safety of opevesostat (MK-5684), a CYP11A1 inhibitor, combined with hormone replacement therapy (HRT), compared to alternative next-generation hormonal agents—abiraterone acetate or enzalutamide—in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after one prior hormonal therapy. The primary endpoints include radiographic progression-free survival and overall survival, assessed in both androgen receptor ligand-binding domain mutation-positive and -negative populations.