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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

2026-09-19

Last Updated

2025-07-08

Healthy Volunteers

No

Interventions

DRUG

Enzalutamide

DRUG

Placebo (No longer applicable in Open Label study period)

Sugar pill to mimic enzalutamide

DRUG

Leuprolide Open Label

Locations (247)

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

Alaska Urological Institute dba Alaska Clinical Research Center

Anchorage, Alaska, United States

Urological Associates of Southern Arizona, PC

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

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

Harrison, 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

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

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

Philadelphia, Pennsylvania, United States

Honickman Centre

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital, Bodine Buiding

Philadelphia, Pennsylvania, United States

Thomas Jefferson University, Medical Oncology

Philadelphia, Pennsylvania, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery

Nashville, Tennessee, United States

Vanderbilt Unversity Medical Center, The Urology Clinic

Nashville, Tennessee, United States

Urology Clinics of North Texas, PLLC

Dallas, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Urology San Antonio Research

San Antonio, Texas, United States

Henrico Doctor's Hospital

Henrico, Virginia, United States

Virginia Urology

Richmond, Virginia, United States

Urology of Virginia, PLLC.

Virginia Beach, Virginia, United States

Genesis Cancer Care NSW

Gateshead, New South Wales, Australia

Lismore Base hospital

Lismore, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Macquarie University

North Ryde, New South Wales, Australia

Genesis Cancer Care

North Sydney, New South Wales, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

GenesisCare North Shore

St Leonards, New South Wales, Australia

The Tweed Hospital

Tweed Heads, New South Wales, Australia

Australian Clinical Trials Pty Ltd

Wahroonga, New South Wales, Australia

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Illawarra Cancer Care Centre

Wollongong, New South Wales, Australia

Crown Princess Mary Cancer Centre

Westmead, NEW, Australia

Icon Cancer Care Wesley

Auchenflower, Queensland, Australia

Icon Cancer Care Chermside

Chermside, Queensland, Australia

Icon Cancer Care South Brisbane

South Brisbane, Queensland, Australia

Icon Cancer Foundation

South Brisbane, Queensland, Australia

Icon Cancer Centre Southport

Southport, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Australian Urology Associates

Malvern, Victoria, Australia

Sunshine Hospital

St Albans, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Hospital Barmherzige Schwestern Linz

Linz, Upper Austria, Austria

Hospital Barmherzige Schwestern Linz, Department of Urology

Linz, Austria

Ordensklinikum Linz GmbH

Linz, Austria

Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria

Salzburg, Austria

Department of Radiology, University Hospital Salzburg, Austria

Salzburg, Austria

Department of Urology,Paracelsus Medical University Salzburg

Salzburg, Austria

AKH - Medizinische Universität Wien

Vienna, Austria

Department of Internal Medicine I, Medical university Vienna

Vienna, Austria

Hospital São Rafael S.A

Salvador, Estado de Bahia, Brazil

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP

Campinas, São Paulo, Brazil

Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda

Ijuí/RS, Brazil

Prostate Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Vancouver Prostate Centre

Vancouver, British Columbia, Canada

Manitoba Prostate Centre CancerCare Manitoba

Winnipeg, Manitoba, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

The Male/Female Health and Research Centre, Royal Court Medical Centre

Barrie, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

Centre for Applied Urological Research

Kingston, Ontario, Canada

Hotel Dieu Hospital

Kingston, Ontario, Canada

Urology Associates/ Urologic Medical Research

Kitchener, Ontario, Canada

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Urology South Shore Research

Greenfield Park, Quebec, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Ultra-Med Inc.

Pointe-Claire, Quebec, Canada

CHU de Quebec - L'Hotel-Dieu de Quebec

Québec, Quebec, Canada

CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO

Québec, Quebec, Canada

Rigshospitalet - Copenhagen University Hospital

Copenhagen N, Copenhagen N, Denmark

Aarhus University Hospital

Arhus N, Denmark

Rigshospitalet - Copenhagen University Hospital

Copenhagen, Denmark

Rigshospitalet, Dept of Radiology

Copenhagen, Denmark

Odense University Hospital

Odense C, Denmark

Vejle Sygehus

Vejle, Denmark

Helsingin yliopistollinen keskussairaala

Helsinki, Finland

Oulun yliopistollinen sairaala

Oulu, Finland

Satakunnan Keskussairaala

Pori, Finland

Seinaejoen Keskussairaala

Seinäjoki, Finland

Tampereen yliopistollinen sairaala

Tampere, Finland

ICO- site Paul Papin

Angers, France

Clinique Pasteur - Lanroze Service Pharmacie

Brest, France

Clinique Pasteur - Lanroze

Brest, France

CHD Vendée

La Roche-sur-Yon, France

CHRU de Lille - Hopital Claude Huriez

Lille, France

ICM Val d'Aurelle

Montpellier, France

CHU de Nantes - Hotel Dieu

Nantes, France

Hopital Saint-Louis

Paris, France

Institut Mutualiste Montsouris

Paris, France

CHP Saint-Gregoire

Saint-Grégoire, France

ICO - site Rene Gauducheau

Saint-Herblain, France

Hia Begin

Saint-Mandé, France

Hopital Foch

Suresnes, France

Institut Gustave Roussy

Villejuif, France

Institut Gustave Roussy

Villejuif, France

Farmacia, Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Italy

Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Italy

UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Italy

UO di Oncologia,Ospedale Civile degli Infermi

Faenza RA, Italy

UO di Radiologia, Ospedale Civile degli Infermi

Faenza RA, Italy

UO di Oncologia, Ospedale Civile Umberto I

Lugo RA, Italy

Uo di Radiologia, Ospedale Civile Umberto I

Lugo RA, Italy

Laboratorio Farmaci Antiblastici, IRCCS Istituto

Meldola (FC), Italy

U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola (FC), Italy

UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)

Meldola (FC), Italy

Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A

Naples, Italy

S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga

Orbassano (TO), Italy

S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga

Orbassano (TO), Italy

Servizio di Farmacia, Ospedale Santa Maria delle Croci

Ravenna, Italy

Servizio di Radiologia, Ospedale Santa Maria Delle Croci

Ravenna, Italy

UO di Oncologia Medica, Ospedale Santa Maria delle Croci

Ravenna, Italy

Farmacia Interna, Ospedale degli Infermi

Rimini, Italy

UO Oncologia, Ospedale degli Infermi

Rimini, Italy

Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani

Roma, Italy

U.O. di Oncologia Medica, Ospedale Santa Chiara

Trento, Italy

U.O. Medicina Nucleare, Ospedale Santa Chiara

Trento, Italy

U.O. Radiologia, Ospedale Santa Chiara

Trento, Italy

VU Medical Centrum, Department of Urology

Amsterdam, Netherlands

Academisch Medisch Centrum

Amsterdam, Netherlands

Gelderse Vallei Ziekenhuis

Ede, Netherlands

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

University Medical Centrum Groningen, Department Urologie

Groningen, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Maastricht University Medical Center, Department of Urology

Maastricht, Netherlands

Antonius Ziekenhuis

Sneek, Netherlands

Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

Gdansk, Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.

Słupsk, Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny

Słupsk, Poland

Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o

Torun, Poland

Centrum Medyczne Melita Medical

Wroclaw, Poland

EMC Instytut Medyczny Spolka Akcyjna

Wroclaw, Poland

Fakultna nemocnica s poliklinikou F.D.Roosevelta

Banská Bystrica, Slovakia

CUIMED, s.r.o., Urologicka ambulancia

Bratislava, Slovakia

Vychodoslovensky onkologicky ustav, a.s.

Košice, Slovakia

Univerzitna nemocnica Martin

Martin, Slovakia

UROEXAM, spol. s r.o.

Nitra, Slovakia

MILAB

Prešov, Slovakia

Fakultna nemocnica s poliklinikou Zilina

Žilina, Slovakia

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Severance Hospital. Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, Spain

Althaia, Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, LA Coruna, Spain

Hospital del Mar

Barcelona, Spain

Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio

Barcelona, Spain

Hospital Universitario Puerta del Mar

Cadiz, Spain

ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia

Girona, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.

Madrid, Spain

Centro Oncologico MD Anderson International Espana

Madrid, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Complejo Hospitalario Universitario de Orense

Ourense, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Instituto Valenciano de Oncologia IVO

Valencia, Spain

Sahlgrenska Universitetssjukhuset, Sahlgrenska

Gothenburg, Sweden

Skanes Universitetssjukhus

Malmo, Sweden

Universitetssjukhuset Orebro

Örebro, Sweden

Sodersjukhuset AB

Stockholm, Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Norrlands Universitetssjukhus

Umeå, Sweden

Norrlands Universitetssjukhus

Umeå, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Ross Hall Hospital

Glasgow, CITY of Glasgow, United Kingdom

Royal Devon & Exeter Hospital

Wonford, Devon, United Kingdom

Royal Free Hospital

London, Greater London, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Cancer Centre, Queen Elizabeth Hospital

Birmingham, WEST Midlands, United Kingdom

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom