A Multicenter Phase 2, Randomized, Double-Blind, Efficacy and Safety Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer Who Have Failed Primary Androgen Deprivation Therapy
This study is a multicenter Phase 2, randomized, double-blind, efficacy and safety study of
enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate
cancer who have serologic and/or radiographic disease progression despite primary androgen
deprivation therapy.
Throughout the study, safety and tolerability will be assessed by the recording of adverse
events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression Free Survival (PFS)
24 months
No
Fong Wang, MD, PhD
Study Director
Medivation, Inc.
United States: Food and Drug Administration
MDV3100-09
NCT01664923
July 2012
July 2014
Name | Location |
---|---|
Bettendorf, Iowa 52722 | |
Alexandria, Minnesota 56308 | |
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
McLean, Virginia 22101 | |
Omaha, Nebraska 68114 | |
Hackensack, New Jersey 07601 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Milwaukee, Wisconsin | |
Indianapolis, Indiana | |
Charleston, South Carolina | |
Washington, District of Columbia | |
Salt Lake City, Utah 84112 |