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    AR antagonist increases survival vs. older agent

     

    “The results of this study showed that enzalutamide provides a longer duration of disease control in the studied patient population compared to bicalutamide,” TERRAIN co-principal investigator Neal Shore, MD, of Carolina Urologic Research Center, Myrtle Beach, SC, said in a news release from Medivation Inc. and Astellas Pharma Inc. “This robust data set adds to an impressive and consistent body of data for enzalutamide across multiple studies and stages of prostate cancer.”

    The TERRAIN trial enrolled 375 patients in North America and Europe. It included patients with metastatic prostate cancer whose disease progressed despite treatment with luteinizing hormone-releasing hormone (LHRH) analogue therapy or following surgical castration. PFS, the primary endpoint, was defined as time from randomization to centrally confirmed radiographic progression, skeletal-related event, initiation of new anti-neoplastic therapy, or death, whichever occurs first.

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    The trial was designed to evaluate enzalutamide at a dose of 160 mg taken once daily versus bicalutamide at a dose of 50 mg taken once daily, the approved dose in combination with an LHRH analogue. Targeted enrollment was completed in July 2013.

    Dr. Shore is an investigator and advisory board member for Astellas and Medivation.


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