According to information released today by Astellas Pharma and Medivation, the PREVAIL trial of MDV3100 (also now known as enzalutamide) in men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) is fully enrolled.
The joint company media release states only that:
The randomized, double-blind, placebo-controlled, multi-national Phase 3 PREVAIL trial has enrolled 1,680 patients at sites in the United States, Canada, Europe, Australia, Asia and Israel. The trial enrolled patients with metastatic prostate cancer who progressed despite treatment with androgen deprivation therapy. The co-primary endpoints of the trial are overall survival and progression-free survival; secondary endpoints include time to first skeletal-related event and time to initiation of chemotherapy. The trial is designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care.
It also notes that study centers in some selected Asian areas will remain open “to gain additional information in these unique populations.”
There is no formal comment from the companies about when they might expect to have data based on overall survival allowing for breaking the blind on this study.
For the benefit of some readers, we note that the PREVAIL trial for enzaluamide is comparable to the so-called 302 study of abiraterone acetate from which data was just reported at the annual meeting of the American Society of Clinical Oncology (ASCO) in the past few days.