Spots Global Cancer Trial Database for Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
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Trial Identification
Brief Title: Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
Official Title: STRIVE: A MULTICENTER PHASE 2, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE VS. BICALUTAMIDE IN MEN WITH PROSTATE CANCER WHO HAVE FAILED PRIMARY ANDROGEN DEPRIVATION THERAPY
Study ID: NCT01664923
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.
Detailed Description: 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. Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to unblinding will be offered the opportunity to receive open label enzalutamide treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Alabama at Birmingham，IDS Pharmacy, Birmingham, Alabama, United States
University of Alabama at Birmingham, Birmingham, Alabama, United States
Desert Springs Cancer Care, Scottsdale, Arizona, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
Urological Associates of Southern Arizona, PC, Tucson, Arizona, United States
Urological Associates of Southern Arizona, PC, Tucson, Arizona, United States
Southern California Permanente Medical Group, Anaheim, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Antioch, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Antioch, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Fairfield, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Gilroy, California, United States
Southern California Permanente Medical Group, Los Angeles, California, United States
Tower Urology, Los Angeles, California, United States
UCLA Clark Urology Clinic, Los Angeles, California, United States
UCLA Department of Pharmaceutical Services, Los Angeles, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Martinez, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Milpitas, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Modesto, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Moutain View, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Napa, California, United States
Kaiser Permanente Medical Center, Oakland, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Pleasanton, California, United States
Kaiser Permanente Medical Center Lab Drawing Station, Redwood City, California, United States
Kaiser Permanente Medical Center, Roseville, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
UC Davis Medical Center, Sacramento, California, United States
Kaiser Permanente Medical Center, Sacramento, California, United States
San Bernardino Urological Associates Medical Group, San Bernardino, California, United States
Southern California Permanente Medical Group, San Diego, California, United States
Kaiser Permanente Medical Center, San Francisco, California, United States
Kaiser Permanente Medical Center, San Jose, California, United States
Kaiser Permanente Medical Center, San Leandro, California, United States
Southern California Permanente Medical Group, San Marcos, California, United States
Kaiser Permanente Medical Center, Santa Clara, California, United States
Skyline Urology, Sherman Oaks, California, United States
Kaiser Permanente Medical Center, South San Francisco, California, United States
Standford Health Care, Stanford, California, United States
Skyline Urology, Torrance, California, United States
Kaiser Permanente Medical Center, Vallejo, California, United States
Kaiser Permanente Medical Center, Walnut Creek, California, United States
Anschutz Cancer Center Pavilion Pharmacy, Aurora, Colorado, United States
Anschutz Inpatient Pavilion, Aurora, Colorado, United States
University of Colorado Cancer Center, Anschutz Cancer Pavilion, Aurora, Colorado, United States
The Urology Center of Colorado, Denver, Colorado, United States
George Washington University - Medical Faculty Associates, Washington, District of Columbia, United States
Advanced Urology institute, Daytona Beach, Florida, United States
East Coast Institute for Research, LLC, Jacksonville, Florida, United States
East Coast Institute for Research, LLC, Jacksonville, Florida, United States
Specialists In Urology, Naples, Florida, United States
First Urology, PSC, Jeffersonville, Indiana, United States
Metairie Oncologist, LLC, Metairie, Louisiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Regional Urology, LLC, Shreveport, Louisiana, United States
Chesapeake Urology Research Associates, Towson, Maryland, United States
Michigan Institute of Urology, Troy, Michigan, United States
Minnesota Oncology Hematology, P.A., Edina, Minnesota, United States
Minnesota Oncology Hematology, P.A., Woodbury, Minnesota, United States
Barnes-Jewish West County Hospital, Creve Coeur, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University Infusion Center Pharmacy, Saint Louis, Missouri, United States
Washington University, School of Medicine, 7th Floor, Center for Advanced Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
GU Research network,LLC / Urology Cancer Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
AccuMed Research Associates, Garden City, New York, United States
Premier Medical Group of the Hudson Valley PC, Poughkeepsie, New York, United States
Associated Medical Professionals of NY, PLLC, Syracuse, New York, United States
Carolinas Medical Center-Steelcreek, Charlotte, North Carolina, United States
Carolina Clinical Trials, LLC, Concord, North Carolina, United States
Carolina Urology Partners, PLLC, Concord, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Investigational Chemotherapy Services, Durham, North Carolina, United States
Alliance Urology Specialists, PA, Greensboro, North Carolina, United States
Rowan Regional Medical Center, Salisbury, North Carolina, United States
Wake Forest Baptist Health Urology, Winston-Salem, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
TriState Urologic Services PSC Inc., dba The Urology Group, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States
Peace Harbor Hospital, Florence, Oregon, United States
Salem Hospital, Salem, Oregon, United States
Oregon Urology Institute, Springfield, Oregon, United States
Sacred Heart Nuclear Medicine, Springfield, Oregon, United States
Lancaster Urology, Lancaster, Pennsylvania, United States
Jefferson Medical Oncology, Philadelphia, Pennsylvania, United States
Jefferson Urology Associates, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
UPMC Cancer Center Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Mount Nittany Physician Group, State College, Pennsylvania, United States
Mount Nittany Health, State College, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology Associates P.C., Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Urology Clinics of North Texas, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology-Memorial City, Houston, Texas, United States
Urology San Antonio Research, San Antonio, Texas, United States
University of Utah/Huntsman Cancer Hospital, Salt Lake City, Utah, United States
University of Utah/Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Oncology Associates, Hampton, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Urology of Virginia, PLLC., Virginia Beach, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
University of Wisconsin Clinical Sciences Center, Madison, Wisconsin, United States
Contact Details
Name: Pfizer Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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