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Completed Phase 3 Interventional Results available

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

ClinicalTrials.gov ID: NCT01212991

Public ClinicalTrials.gov record NCT01212991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 9:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01212991
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
1,717 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 16, 2010 (Actual)
Primary completion
Sep 30, 2013 (Actual)
Completion
Feb 14, 2019 (Actual)
Last update posted
Mar 17, 2020

2010 – 2019

United States locations

U.S. sites
65
U.S. states
21
U.S. cities
37
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35249 —
University of Alabama at Birmingham Birmingham Alabama 35294 —
The University of Arizona Cancer Center-North Campus Tucson Arizona 85719 —
The University of Arizona Cancer Certer-North Campus Tucson Arizona 85719 —
Cancer Center Oncology Medical Group La Mesa California 91942 —
Keck Hospital of USC Los Angeles California 90033 —
LAC&USC Medical Center Los Angeles California 90033 —
USC/Norris Comprehensive Cancer Center / Investigational Drug Services Los Angeles California 90033 —
USC/Norris Comprehensive Cancer Center Los Angeles California 90033 —
Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services Los Angeles California 90095 —
UCLA Clark Urology Clinic Los Angeles California 90095 —
North County Oncology Medical Clinic, Inc Oceanside California 92056 —
UC Davis Medical Center Sacramento California 95817 —
University of California Davis Comprehensive Cancer Center Sacramento California 95817 —
Medical Oncology Associates-SD San Diego California 92123 —
Sharp Memorial Hospital Investigational Pharmacy San Diego California 92123 —
Sharp Rees-Stealy San Diego California 92123 —
Stanford University Medical Center Stanford California 94305 —
Anschutz Cancer Center Pavilion Pharmacy Aurora Colorado 80045 —
University of Colorado Hospital, Anschutz Cancer Pavilion Aurora Colorado 80045 —
Lynn Cancer Institute Center for Hematology Oncology Boca Raton Florida 33486 —
Northwestern Medical Faculty Foundation Chicago Illinois 60611 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
Jewish Hospital & St. Mary's Healthcare, Inc. Louisville Kentucky 40245 —
Brigham & Women's Hospital Boston Massachusetts 02115 —
Beth Israel Deaoness Medical Center Boston Massachusetts 02215 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
Karmanos Cancer Institute Detroit Michigan 48201 —
Karmanos Cancer Institute Weisberg Cancer Treatment Center Farmington Hills Michigan 48334 —
Mayo Clinic Rochester Minnesota 55905 —
Barnes-Jewish St. Peters Hospital City of Saint Peters Missouri 63376 —
Barnes-Jewish West County Hospital Creve Coeur Missouri 63141 —
BJH Pharmacy St Louis Missouri 63108 —
Barnes-Jewish Hospital St Louis Missouri 63110 —
Washington University School of Medicine St Louis Missouri 63110 —
Nebraska Methodist Hospital Omaha Nebraska 68114 —
The Mount Sinai Medical Center New York New York 10029 —
Memorial Sloan-Kettering Cancer Center New York New York 10065 —
Cancer Centers of North Carolina Cary North Carolina 27518 —
Levine Cancer Institute Charlotte North Carolina 28203 —
Levine Cancer Institute - Main Charlotte North Carolina 28204 —
Levine Cancer Institute - Southpark Charlotte North Carolina 28211 —
Levine Cancer Institute - University Charlotte North Carolina 28262 —
Levine Cancer Institute - Ballantyne Charlotte North Carolina 28277 —
Duke University Medical Center Durham North Carolina 27710 —
Investigational Chemotherapy Services Durham North Carolina 27710 —
Cancer Centers of North Carolina Raleigh North Carolina 27607 —
Portland VA Medical Center Laboratory Portland Oregon 97239 —
Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine Philadelphia Pennsylvania 19104 —
UPMC Presbyterian Pittsburgh Pennsylvania 15213 —
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 —
Hematology / Oncology MUSC Hollings Cancer Center Charleston South Carolina 29425 —
Medical University of South Carolina - Urology Services Charleston South Carolina 29425 —
MUSC Department of Radiology Charleston South Carolina 29425 —
MUSC Urology Ambulatory Care Charleston South Carolina 29425 —
MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor Mt. Pleasant South Carolina 29464 —
MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor Mt. Pleasant South Carolina 29464 —
UT Southwestern Medical Center at Dallas Dallas Texas 75390 —
Virginia Oncology Associates Hampton Virginia 23666 —
Virginia Oncology Associates Newport News Virginia 23606 —
Virginia Oncology Associates Norfolk Virginia 23502 —
Virginia Oncology Associates Virginia Beach Virginia 23456 —
Seattle Cancer Care Alliance Seattle Washington 98109 —
University of Washington Medical Center Seattle Washington 98195 —
University of Wisconsin Hospital and Clinics Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 204 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01212991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 17, 2020 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01212991 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →