Phase 2 Study of Talazoparib With or Without Enzalutamide for Men with Metastatic Castration-Resistant Prostate Cancer Having HRR Mutations After Abiraterone Acetate Treatment

What this Trial Is About

Researchers are evaluating whether talazoparib combined with enzalutamide or talazoparib alone can delay cancer progression in men with metastatic castration-resistant prostate cancer mCRPC who have specific mutations affecting DNA repair and have previously been treated with abiraterone acetate. This phase 2 study focuses on patients with homologous recombination repair HRR gene mutations and aims to compare these two treatment approaches in this population. The trial has two treatment groups one receives talazoparib at 0.5 mg daily combined with enzalutamide at 160 mg daily, both administered in continuous 28-day cycles, while the other group receives talazoparib alone at 1 mg daily on the same schedule. Participants continue treatment in these cycles and are monitored throughout the study period. Participants undergo regular assessments including scans and laboratory tests to track cancer progression, PSA levels, quality of life, cognitive and fatigue status, and adverse events. The main outcome measured is radiographic progression-free survival, with follow-up extending up to about 42 months from enrollment start. Safety and overall survival are also closely monitored, with follow-up continuing up to 12 months after treatment ends. Participation duration varies depending on individual treatment response and study timelines.

A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate