Iheya

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are investigating the effects of opevesostat compared to alternative treatments abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC). This phase 3, randomized, open-label study focuses on participants who have already been treated with next-generation hormonal agents and taxane-based chemotherapy. The study aims to assess overall survival (OS) in participants with and without androgen receptor ligand binding domain (AR LBD) mutations, hypothesizing that opevesostat may improve survival. Participants will receive either oral opevesostat or an alternative hormonal agent such as abiraterone acetate or enzalutamide. Additional supportive medications like hydrocortisone, fludrocortisone acetate, prednisone, or dexamethasone may be given orally or as needed. The study compares these treatments directly during the trial period. Throughout the study, participants will provide tumor tissue samples and undergo regular assessments including imaging scans, laboratory tests, and performance status evaluations. Researchers will monitor overall survival for up to approximately 54 months, differentiating outcomes based on AR LBD mutation status. Safety and treatment effects will be carefully tracked during this time to evaluate the benefits and risks of the treatments.