Phase II Study Comparing Inavolisib Plus Enzalutamide to Physicians Choice of Treatment in Men With Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining inavolisib with enzalutamide compared to a physicians choice of an alternative androgen receptor pathway inhibitor or docetaxel in men with metastatic castration-resistant prostate cancer mCRPC. This study focuses on participants who have already received one prior second-generation androgen receptor pathway inhibitor and have specific biomarker characteristics. The goal is to find better treatment options for this advanced prostate cancer stage. Participants will be randomly assigned to one of two groups. One group will receive oral inavolisib combined with oral enzalutamide. The other group will receive either an alternative androgen receptor pathway inhibitor enzalutamide or abiraterone taken orally or docetaxel administered intravenously, depending on the physicians choice. The study is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will be monitored for radiographic progression-free survival for up to approximately five years. Additional measurements include response rates, prostate-specific antigen levels, duration of response, overall survival, and adverse events. Researchers will perform assessments at regular intervals to track these outcomes and ensure participant safety throughout the trial period.

A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer