Astellas, Medivation Begin CRPC Enrollment

Medivation and Astellas Pharma have enrolled the first patient in a global Phase III clinical trial that will evaluate the safety and efficacy of enzalutamide in patients with non-metastatic (often referred to as M0) castration-resistant prostate cancer (CRPC). Currently no prescription medicine is specifically approved for the treatment of patients with non-metastatic CRPC in the U.S.

The randomized, double-blind, placebo-controlled, multi-national trial will enroll approximately 1,500 patients with non-metastatic CRPC at sites in the U.S., Canada, Europe, South America and the Asia-Pacific region. The trial will enroll a high-risk subgroup of patients with prostate cancer who are progressing despite androgen deprivation therapy, but who are asymptomatic with no prior or present evidence of metastatic disease. The primary endpoint of the trial is metastasis-free survival. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily versus placebo, plus androgen deprivation therapy.