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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,068

Participants

Timeline

Start Date

December 17, 2014

Primary Completion Date

January 31, 2023

Study Completion Date

September 19, 2026

Conditions
Hormone Sensitive Prostate CancerProstate CancerCancer 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Placebo (No longer applicable in Open Label study period)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

Trial Locations (247)

333

Chang Gung Memorial Hospital, Linkou, Taoyuan District

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1090

AKH - Medizinische Universität Wien, Vienna

Department of Internal Medicine I, Medical university Vienna, Vienna

2060

Genesis Cancer Care, North Sydney

2065

GenesisCare North Shore, St Leonards

2076

Australian Clinical Trials Pty Ltd, Wahroonga

Sydney Adventist Hospital, Wahroonga

2100

Rigshospitalet - Copenhagen University Hospital, Copenhagen

Rigshospitalet, Dept of Radiology, Copenhagen

2109

Macquarie University, North Ryde

2145

Westmead Hospital, Westmead

Crown Princess Mary Cancer Centre, Westmead

2170

Liverpool Hospital, Liverpool

2200

Rigshospitalet - Copenhagen University Hospital, Copenhagen N

2290

Genesis Cancer Care NSW, Gateshead

2298

Calvary Mater Newcastle, Waratah

2444

Port Macquarie Base Hospital, Port Macquarie

2480

Lismore Base hospital, Lismore

2485

The Tweed Hospital, Tweed Heads

2500

Illawarra Cancer Care Centre, Wollongong

3021

Sunshine Hospital, St Albans

3084

Austin Health, Heidelberg

3128

Box Hill Hospital, Box Hill

3144

Australian Urology Associates, Malvern

3168

Monash Medical Centre, Clayton

4010

Hospital Barmherzige Schwestern Linz, Linz

Hospital Barmherzige Schwestern Linz, Department of Urology, Linz

4020

Ordensklinikum Linz GmbH, Linz

4032

Icon Cancer Care Chermside, Chermside

4066

Icon Cancer Care Wesley, Auchenflower

4101

Icon Cancer Care South Brisbane, South Brisbane

Icon Cancer Foundation, South Brisbane

4215

Icon Cancer Centre Southport, Southport

5000

Royal Adelaide Hospital, Adelaide

Odense University Hospital, Odense C

5020

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

Department of Radiology, University Hospital Salzburg, Austria, Salzburg

Department of Urology,Paracelsus Medical University Salzburg, Salzburg

6150

Fiona Stanley Hospital, Murdoch

7100

Vejle Sygehus, Vejle

8200

Aarhus University Hospital, Arhus N

10002

National Taiwan University Hospital, Taipei

10043

S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga, Orbassano (TO)

S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga, Orbassano (TO)

10065

Memorial Hospital, New York

Sidney Kimmel Center for Prostate and Urologic Cancers, New York

10604

Memorial Sloan Kettering Cancer Center Westchester, Harrison

11009

Hospital Universitario Puerta del Mar, Cadiz

11553

Memorial Sloan Kettering Cancer Center Nassau, Uniondale

11570

Memorial Sloan Kettering Cancer Center Rockville Centre, Rockville Centre

11725

Memorial Sloan Kettering Cancer Center Commack, Commack

12603

Premier Medical Group of the Hudson Valley PC, Poughkeepsie

13210

Associated Medical Professionals of New York, PLLC, Syracuse

13620

Seoul National University Bundang Hospital, Seongnam-si

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

17007

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

17176

Karolinska Universitetssjukhuset Solna, Stockholm

17604

Keystone Urology Specialists, Lancaster

19004

Urologic Consultants of SE PA, Bala-Cynwyd

19083

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

19107

Honickman Centre, Philadelphia

Thomas Jefferson University Hospital, Bodine Buiding, Philadelphia

Thomas Jefferson University, Medical Oncology, Philadelphia

Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia

21204

Chesapeake Urology Research Associates, Towson

21287

John Hopkins University Hospital, Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

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

21565

Gachon University Gil Medical Center, Incheon

23229

Henrico Doctor's Hospital, Henrico

23235

Virginia Urology, Richmond

23462

Urology of Virginia, PLLC., Virginia Beach

26100

Farmacia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona

Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona

UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona

27403

Alliance Urology Specialists, PA, Greensboro

27710

Duke Investigational Chemotherapy Services, Durham

Duke Nuclear Medicine, Durham

Duke University Medical Center, Durham

28006

Hospital Universitario de La Princesa, Madrid

28007

Hospital General Universitario Gregorio Maranon. Servicio de Oncologia., Madrid

28033

Centro Oncologico MD Anderson International Espana, Madrid

28034

Hospital Universitario Ramon Y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28500

Satakunnan Keskussairaala, Pori

29200

Clinique Pasteur - Lanroze Service Pharmacie, Brest

Clinique Pasteur - Lanroze, Brest

29572

Carolina Urologic Research Center, Myrtle Beach

30322

Emory University Hospital, Atlanta

Winship Cancer Institute, Emory University, Atlanta

32005

Complejo Hospitalario Universitario de Orense, Ourense

33520

Tampereen yliopistollinen sairaala, Tampere

33805

Lakeland Regional Health Hollis Cancer Center, Lakeland

34298

ICM Val d'Aurelle, Montpellier

35233

University of Alabama at Birmingham, Birmingham

35249

University of Alabama at Birmingham, IDS Pharmacy, Birmingham

University of Alabama at Birmingham, Birmingham

35760

CHP Saint-Gregoire, Saint-Grégoire

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37232

Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery, Nashville

Vanderbilt Unversity Medical Center, The Urology Clinic, Nashville

38122

U.O. di Oncologia Medica, Ospedale Santa Chiara, Trento

U.O. Medicina Nucleare, Ospedale Santa Chiara, Trento

U.O. Radiologia, Ospedale Santa Chiara, Trento

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

44000

CHU de Nantes - Hotel Dieu, Nantes

44130

Clinical Research Solutions, Middleburg Heights

Southwest Urology, Middleburg Heights

44805

ICO - site Rene Gauducheau, Saint-Herblain

45212

TriState Urologic Services PSC Inc., dba The Urology Group, Cincinnati

45236

Mercy Health Jewish Hospital, Cincinnati

46009

Instituto Valenciano de Oncologia IVO, Valencia

47014

Laboratorio Farmaci Antiblastici, IRCCS Istituto, Meldola (FC)

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

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

47130

First Urology, PSC, Jeffersonville

47923

Farmacia Interna, Ospedale degli Infermi, Rimini

UO Oncologia, Ospedale degli Infermi, Rimini

48018

UO di Oncologia,Ospedale Civile degli Infermi, Faenza RA

UO di Radiologia, Ospedale Civile degli Infermi, Faenza RA

48022

UO di Oncologia, Ospedale Civile Umberto I, Lugo RA

Uo di Radiologia, Ospedale Civile Umberto I, Lugo RA

48044

Comprehensive Urology - Macomb Office, Macomb

48067

Comprehensive Urology - Royal Oak (Stephenson) office, Royal Oak

48121

Servizio di Farmacia, Ospedale Santa Maria delle Croci, Ravenna

Servizio di Radiologia, Ospedale Santa Maria Delle Croci, Ravenna

UO di Oncologia Medica, Ospedale Santa Maria delle Croci, Ravenna

49933

ICO- site Paul Papin, Angers

50612

Pusan National University Yangsan Hospital, Yangsan

58128

Chonnam National University Hwasun Hospital, Hwasun-gun

59037

CHRU de Lille - Hopital Claude Huriez, Lille

60220

Seinaejoen Keskussairaala, Seinäjoki

60611

Northwestern Medical Group, Chicago

Northwestern Memorial Hospital, Chicago

66160

The University of Kansas Hospital, Kansas City

66205

The University of Kansas Cancer Center and Medical Pavilion, Westwood

66211

Kansas City Urology Care, PA, Overland Park

67226

GU Research Network/Wichita Urology Group, Wichita

68130

GU Research Network, LLC / Urology Cancer Center, Omaha

73104

Stephenson Cancer Center, Oklahoma City

75231

Urology Clinics of North Texas, PLLC, Dallas

75475

Hopital Saint-Louis, Paris

75674

Institut Mutualiste Montsouris, Paris

77027

Houston Metro Urology, Houston

78229

Urology San Antonio Research, San Antonio

80131

Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A, Napoli

80211

The Urology Center of Colorado, Denver

80401

Foothills Urology, P.C., Golden

85741

Urological Associates of Southern Arizona, PC, Tucson

85925

CHD Vendée, La Roche-sur-Yon

89406

VA Lahontan Valley Outpatient Clinic, Fallon

90048

Cedars-Senai OCC Pharmacy, Los Angeles

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles

90185

Norrlands Universitetssjukhus, Umeå

90211

Tower Hematology Oncology Medical Group, Beverly Hills

90220

Oulun yliopistollinen sairaala, Oulu

92151

Hopital Foch, Suresnes

92868

University of California, Irvine Medical Center, Orange

94160

Hia Begin, Saint-Mandé

94800

Institut Gustave Roussy, Villejuif

94805

Institut Gustave Roussy, Villejuif

95661

Sutter Medical Group, Vascular & Varicose Vein Center, Roseville

Sutter Medical Group, Roseville

95817

UC Davis Comprehensive Cancer Center, Sacramento

University of California Davis Medical Center, Sacramento

University of California, Davis, School of Medicine, Sacramento

97401

Oregon Imaging Center, Eugene

97477

Oregon Urology Institute, Springfield

99503

Alaska Urological Institute dba Alaska Clinical Research Center, Anchorage

06360

Eastern Connecticut Hematology Oncology Associates, Norwich

07920

Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge

41253-190

Hospital São Rafael S.A, Salvador

81520-060

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner, Curitiba

99010-260

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

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

90430-090

CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda., Porto Alegre

90610-0000

Hospital Sao Lucas da PUCRS, Porto Alegre

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos

13083-970

Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP, Campinas

09060-650

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

98700-000

Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda, Ijuí/RS

T2V 1P9

Prostate Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 1M9

Vancouver Prostate Centre, Vancouver

R3E 0V9

Manitoba Prostate Centre CancerCare Manitoba, Winnipeg

B3H 2Y9

Nova Scotia Health Authority, Halifax

L4M 7G1

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

K7L 2V7

Kingston General Hospital, Kingston

K7L 3J7

Centre for Applied Urological Research, Kingston

K7L 5G2

Hotel Dieu Hospital, Kingston

N2N 2B9

Urology Associates/ Urologic Medical Research, Kitchener

N6A 5W9

London Health Sciences Centre - Victoria Hospital, London

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

University Health Network - Princess Margaret Cancer Centre, Toronto

J4V 2H3

Urology South Shore Research, Greenfield Park

H2X 3E4

Centre Hospitalier de l'Universite de Montreal, Montreal

H4A 3J1

McGill University Health Centre, Montreal

H9R 4S3

Ultra-Med Inc., Pointe-Claire

G1R 2J6

CHU de Quebec - L'Hotel-Dieu de Quebec, Québec

G1R 3S1

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

00290

Helsingin yliopistollinen keskussairaala, Helsinki

00152

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

1081 HV

VU Medical Centrum, Department of Urology, Amsterdam

1105AZ

Academisch Medisch Centrum, Amsterdam

6710 HN

Gelderse Vallei Ziekenhuis, Ede

5623 EJ

Catharina Ziekenhuis Eindhoven, Eindhoven

9713 GZ

University Medical Centrum Groningen, Department Urologie, Groningen

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

6229 HX

Maastricht University Medical Center, Department of Urology, Maastricht

8601 ZK

Antonius Ziekenhuis, Sneek

80-952

Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii, Gdansk

76-200

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

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

87-100

Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o, Torun

50-449

Centrum Medyczne Melita Medical, Wroclaw

54-144

EMC Instytut Medyczny Spolka Akcyjna, Wroclaw

975 17

Fakultna nemocnica s poliklinikou F.D.Roosevelta, Banská Bystrica

851 05

CUIMED, s.r.o., Urologicka ambulancia, Bratislava

041 91

Vychodoslovensky onkologicky ustav, a.s., Košice

036 59

Univerzitna nemocnica Martin, Martin

949 01

UROEXAM, spol. s r.o., Nitra

080 81

MILAB, Prešov

012 07

Fakultna nemocnica s poliklinikou Zilina, Žilina

03722

Severance Hospital. Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

07010

Hospital Universitari Son Espases, Palma de Mallorca

08243

Althaia, Xarxa Assistencial Universitària de Manresa, Manresa

08003

Hospital del Mar, Barcelona

08036

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

08208

Corporacio Sanitaria Parc Tauli, Sabadell

413 45

Sahlgrenska Universitetssjukhuset, Sahlgrenska, Gothenburg

205 02

Skanes Universitetssjukhus, Malmo

70 185

Universitetssjukhuset Orebro, Örebro

118 83

Sodersjukhuset AB, Stockholm

90 185

Norrlands Universitetssjukhus, Umeå

751 85

Akademiska Sjukhuset, Uppsala

G52 3NQ

Ross Hall Hospital, Glasgow

EX2 5DW

Royal Devon & Exeter Hospital, Wonford

NW3 2QG

Royal Free Hospital, London

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

B15 2TH

Cancer Centre, Queen Elizabeth Hospital, Birmingham

BS2 8ED

University Hospitals Bristol NHS Foundation Trust, Bristol

G12 OYN

Beatson West of Scotland Cancer Centre, Glasgow

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

INDUSTRY

lead

Pfizer

INDUSTRY

NCT02319837 - Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) | Biotech Hunter | Biotech Hunter