According to a media release issued earlier today, Medivation and Astellas Pharma have enrolled the first patient into a new Phase III clinical trial of MDV3100. The so-called PREVAIL study is a randomized, double-blind, placebo-controlled, multi-national Phase III trial in patients with metastatic castration-resistrant prostate cancer (mCRPC) who have not previously received chemotherapy. It is expected to enroll approximately 1,700 patients at sites in the United States, Canada, Europe, Australia and Israel. All patients must have clinically evident metastatic prostate cancer and must have progressive disease despite treatment with androgen deprivation therapy. Primary endpoints of this trial are overall survival and progression-free survival.
The trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily + standard of care versus placebo + standard of care. Information about patient eligibility and enrollment can be obtained by calling the PREVAIL study hotline toll-free at 1-888-243-4363. No additional details about this trial are available (yet) on the ClinicalTrials.gov web site.
The Phase III AFFIRM trial of MDV3100 in patients with mCRPC who have progressive disease after treatment with docetaxel-based chemotherapy is ongoing, and is currently expected to complete enrollment by the end of 2010.
Filed under: Drugs in development Tagged: | castration-resistant, mCRPC, MDV3100, Phase III, trial
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