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ACTIVE NOT RECRUITING

NCT02319837

PHASE3

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.

Official title: A PHASE 3, RANDOMIZED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE PLUS LEUPROLIDE, ENZALUTAMIDE MONOTHERAPY, AND PLACEBO PLUS LEUPROLIDE IN MEN WITH HIGH-RISK NONMETASTATIC PROSTATE CANCER PROGRESSING AFTER DEFINITIVE THERAPY

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1068

Start Date

2014-12-17

Completion Date

2027-07-30

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate

Interventions

DRUG

Enzalutamide

DRUG

Placebo (No longer applicable in Open Label study period)

Sugar pill to mimic enzalutamide

DRUG

Leuprolide Open Label

Locations (255)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, United States

Alaska Urological Institute dba Alaska Clinical Research Center

Anchorage, Alaska, United States

Arizona Urology Specialists

Tucson, Arizona, United States

Tower Hematology Oncology Medical Group

Beverly Hills, California, United States

Cedars-Senai OCC Pharmacy

Los Angeles, California, United States

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

University of California, Irvine Medical Center

Orange, California, United States

Sutter Medical Group, Vascular & Varicose Vein Center

Roseville, California, United States

Sutter Medical Group

Roseville, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

University of California Davis Medical Center

Sacramento, California, United States

University of California, Davis, School of Medicine

Sacramento, California, United States

The Urology Center of Colorado

Denver, Colorado, United States

Foothills Urology, P.C.

Golden, Colorado, United States

Eastern Connecticut Hematology Oncology Associates

Norwich, Connecticut, United States

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern Medical Group

Chicago, Illinois, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

First Urology, PSC

Jeffersonville, Indiana, United States

The University of Kansas Hospital

Kansas City, Kansas, United States

Kansas City Urology Care, PA

Overland Park, Kansas, United States

The University of Kansas Cancer Center and Medical Pavilion

Westwood, Kansas, United States

GU Research Network/Wichita Urology Group

Wichita, Kansas, United States

John Hopkins University Hospital

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services

Baltimore, Maryland, United States

Chesapeake Urology Research Associates

Towson, Maryland, United States

Comprehensive Urology - Macomb Office

Macomb, Michigan, United States

Comprehensive Urology - Royal Oak (Stephenson) office

Royal Oak, Michigan, United States

GU Research Network, LLC / Urology Cancer Center

Omaha, Nebraska, United States

VA Lahontan Valley Outpatient Clinic

Fallon, Nevada, United States

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center Westchester

East White Plains, New York, United States

Memorial Hospital

New York, New York, United States

Sidney Kimmel Center for Prostate and Urologic Cancers

New York, New York, United States

Premier Medical Group of the Hudson Valley PC

Poughkeepsie, New York, United States

Premier Medical Group of the Hudson Valley PC

Poughkeepsie, New York, United States

Memorial Sloan Kettering Cancer Center Rockville Centre

Rockville Centre, New York, United States

Associated Medical Professionals of New York, PLLC

Syracuse, New York, United States

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, New York, United States

Duke Investigational Chemotherapy Services

Durham, North Carolina, United States

Duke Nuclear Medicine

Durham, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Alliance Urology Specialists, PA

Greensboro, North Carolina, United States

TriState Urologic Services PSC Inc., dba The Urology Group

Cincinnati, Ohio, United States

Mercy Health Jewish Hospital

Cincinnati, Ohio, United States

Clinical Research Solutions

Middleburg Heights, Ohio, United States

Southwest Urology

Middleburg Heights, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Imaging Center

Eugene, Oregon, United States

Oregon Urology Institute

Springfield, Oregon, United States

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

Jefferson Urology Associates

Phiadelphia, Pennsylvania, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization