PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.
Randomized, Double Blind Treatment Period:
Inclusion Criteria:
Exclusion Criteria:
Open-Label Treatment Period:
The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.
Eligible patients must meet all inclusion criteria.
The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:
Los Angeles, California 90033, United States
Los Angeles, California 90095, United States
Sacramento, California 95817, United States
Farmington Hills, Michigan 48334, United States
Philadelphia, Pennsylvania 19104, United States
Charleston, South Carolina 29425, United States
Mt. Pleasant, South Carolina 29464, United States
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Lismore, New South Wales 2480, Australia
St Leonards, New South Wales 2065, Australia
Kelowna, British Columbia V1Y 5L3, Canada
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Homburg/Saar, 66424, Germany
Weiden in Der Oberpfalz, 92637, Germany
Beer Yaakov, 70300, Israel
Meldola, FC 47014, Italy
Suita-shi, Osaka 5650871, Japan
Bunkyo-ku, Tokyo 1138603, Japan
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Gangnam-gu, Seoul 06351, South Korea
Songpa-gu, Seoul 05505, South Korea
Bebington, Wirral, Merseyside CH63 4JY, United Kingdom
Brighton, East Sussex, BN2 5BE, United Kingdom