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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer; Cancer of the Prostate; Hormone Sensitive Prostate Cancer
• Intervention / Treatment: Drug: Enzalutamide; Drug: Leuprolide Open Label; Drug: Placebo (No longer applicable in Open Label study period)

• Study Type: Interventional
• Enrollment (Actual): 1068
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • NEW
    • Westmead, NEW, Australia, 2145
      • Crown Princess Mary Cancer Centre
  • New South Wales
    • Gateshead, New South Wales, Australia, 2290
      • Genesis Cancer Care NSW
    • Lismore, New South Wales, Australia, 2480
      • Lismore Base Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • North Ryde, New South Wales, Australia, 2109
      • Macquarie University
    • North Sydney, New South Wales, Australia, 2060
      • Genesis Cancer Care
    • Port Macquarie, New South Wales, Australia, 2444
      • Port Macquarie Base Hospital
    • St Leonards, New South Wales, Australia, 2065
      • GenesisCare North Shore
    • Tweed Heads, New South Wales, Australia, 2485
      • The Tweed Hospital
    • Wahroonga, New South Wales, Australia, 2076
      • Australian Clinical Trials Pty Ltd
    • Wahroonga, New South Wales, Australia, 2076
      • Sydney Adventist Hospital
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Illawarra Cancer Care Centre
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Icon Cancer Care Wesley
    • Chermside, Queensland, Australia, 4032
      • Icon Cancer Care Chermside
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care South Brisbane
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Foundation
    • Southport, Queensland, Australia, 4215
      • ICON Cancer Centre Southport
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Malvern, Victoria, Australia, 3144
      • Australian Urology Associates
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Linz, Austria, 4010
    • Hospital Barmherzige Schwestern Linz, Department of Urology
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH
  • Salzburg, Austria, 5020
    • Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria
  • Salzburg, Austria, 5020
    • Department of Radiology, University Hospital Salzburg, Austria
  • Salzburg, Austria, 5020
    • Department of Urology,Paracelsus Medical University Salzburg
  • Vienna, Austria, 1090
    • AKH - Medizinische Universitat Wien
  • Vienna, Austria, 1090
    • Department of Internal Medicine I, Medical university Vienna
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Hospital Barmherzige Schwestern Linz
• Brazil
  • Ijuí/RS, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • BA
    • Salvador, BA, Brazil, 41253-190
      • Hospital São Rafael S.A
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
      • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
  • RS
    • Passo Fundo, RS, Brazil, 99010-260
      • CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, RS, Brazil, 90430-090
      • CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
    • Porto Alegre, RS, Brazil, 90610-0000
      • Hospital São Lucas da PUCRS
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Fundação Pio XII - Hospital de Câncer de Barretos
    • Campinas, SP, Brazil, 13083-970
      • Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
    • Santo Andre, SP, Brazil, 09060-650
      • Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
• Canada
  • Quebec, Canada, G1R 2J6
    • CHU de Quebec - L'Hotel-Dieu de Quebec
  • Quebec, Canada, G1R 3S1
    • CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • Prostate Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver Prostate Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Manitoba Prostate Centre CancerCare Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Nova Scotia Health Authority
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • The Male/Female Health and Research Centre, Royal Court Medical Centre
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • Kingston, Ontario, Canada, K7L 5G2
      • Hotel Dieu Hospital
    • Kingston, Ontario, Canada, K7L 3J7
      • Centre for Applied Urological Research
    • Kitchener, Ontario, Canada, N2N 2B9
      • Urology Associates/ Urologic Medical Research
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre - Victoria Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network - Princess Margaret Cancer Centre
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H3
      • Urology South Shore Research
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Université de Montréal
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Ultra-Med Inc.
• Denmark
  • Arhus N, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet - Copenhagen University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Dept of Radiology
  • Copenhagen N, Denmark, 2200
    • Rigshospitalet - Copenhagen University Hospital
  • Odense C, Denmark, 5000
    • Odense University Hospital
  • Vejle, Denmark, 7100
    • Vejle Sygehus
• Finland
  • Helsinki, Finland, 00290
    • Helsingin Yliopistollinen Keskussairaala
  • Oulu, Finland, 90220
    • Oulun yliopistollinen sairaala
  • Pori, Finland, 28500
    • Satakunnan Keskussairaala
  • Seinaejoki, Finland, 60220
    • Seinaejoen Keskussairaala
  • Tampere, Finland, 33520
    • Tampereen yliopistollinen sairaala
• France
  • Angers cedex 09, France, 49933
    • ICO- site Paul Papin
  • Brest, France, 29200
    • Clinique Pasteur - Lanroze Service Pharmacie
  • Brest, France, 29200
    • Clinique Pasteur - Lanroze
  • LA ROCHE SUR YON cedex 9, France, 85925
    • CHD Vendee
  • Lille cedex, France, 59037
    • CHRU de Lille - Hopital Claude Huriez
  • Montpellier Cedex 5, France, 34298
    • ICM Val d'Aurelle
  • Nantes, France, 44000
    • CHU de Nantes - Hôtel Dieu
  • Paris Cedex 14, France, 75674
    • Institut Mutualiste Montsouris
  • Paris cedex 10, France, 75475
    • Hôpital Saint-Louis
  • Saint-Gregoire, France, 35760
    • CHP Saint-Gregoire
  • Saint-Herblain cedex, France, 44805
    • ICO - Site René Gauducheau
  • Saint-Mande, France, 94160
    • Hia Begin
  • Suresnes, France, 92151
    • Hopital FOCH
  • Villejuif, France, 94800
    • Institut Gustave Roussy
  • Villejuif cedex, France, 94805
    • Institut Gustave Roussy
• Italy
  • Cremona, Italy, 26100
    • Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
  • Cremona, Italy, 26100
    • Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
  • Cremona, Italy, 26100
    • UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
  • Faenza RA, Italy, 48018
    • UO di Oncologia,Ospedale Civile degli Infermi
  • Faenza RA, Italy, 48018
    • UO di Radiologia, Ospedale Civile degli Infermi
  • Lugo RA, Italy, 48022
    • UO di Oncologia, Ospedale Civile Umberto I
  • Lugo RA, Italy, 48022
    • Uo di Radiologia, Ospedale Civile Umberto I
  • Meldola (FC), Italy, 47014
    • Laboratorio Farmaci Antiblastici, IRCCS Istituto
  • Meldola (FC), Italy, 47014
    • U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Meldola (FC), Italy, 47014
    • UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A
  • Orbassano (TO), Italy, 10043
    • S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga
  • Orbassano (TO), Italy, 10043
    • S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga
  • Ravenna, Italy, 48121
    • Servizio di Farmacia, Ospedale Santa Maria delle Croci
  • Ravenna, Italy, 48121
    • Servizio di Radiologia, Ospedale Santa Maria Delle Croci
  • Ravenna, Italy, 48121
    • UO di Oncologia Medica, Ospedale Santa Maria delle Croci
  • Rimini, Italy, 47923
    • Farmacia Interna, Ospedale degli Infermi
  • Rimini, Italy, 47923
    • UO Oncologia, Ospedale degli Infermi
  • Roma, Italy, 00152
    • Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani
  • Trento, Italy, 38122
    • U.O. di Oncologia Medica, Ospedale Santa Chiara
  • Trento, Italy, 38122
    • U.O. Medicina Nucleare, Ospedale Santa Chiara
  • Trento, Italy, 38122
    • U.O. Radiologia, Ospedale Santa Chiara
• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital. Yonsei University Health System
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Gyeongsangnam-do
    • Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital
  • Jeollanam-do
    • Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hospital
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medical Centrum, Department of Urology
  • Amsterdam, Netherlands, 1105AZ
    • Academisch Medisch Centrum
  • Ede, Netherlands, 6710 HN
    • Gelderse Vallei Ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis Eindhoven
  • Groningen, Netherlands, 9713 GZ
    • University Medical Centrum Groningen, Department Urologie
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center, Department of Urology
  • Sneek, Netherlands, 8601 ZK
    • Antonius Ziekenhuis
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
  • Slupsk, Poland, 76-200
    • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.
  • Slupsk, Poland, 76-200
    • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny
  • Torun, Poland, 87-100
    • Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
  • Wroclaw, Poland, 50-449
    • Centrum Medyczne Melita Medical
  • Wroclaw, Poland, 54-144
    • EMC Instytut Medyczny Spolka Akcyjna
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou F.D.Roosevelta
  • Bratislava, Slovakia, 851 05
    • CUIMED, s.r.o., Urologicka ambulancia
  • Kosice, Slovakia, 041 91
    • Vychodoslovensky onkologicky ustav, a.s.
  • Martin, Slovakia, 036 59
    • Univerzitna nemocnica Martin
  • Nitra, Slovakia, 949 01
    • UROEXAM, spol. s r.o.
  • Presov, Slovakia, 080 81
    • MILAB
  • Zilina, Slovakia, 012 07
    • Fakultna nemocnica s poliklinikou Zilina
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio
  • Cadiz, Spain, 11009
    • Hospital Universitario Puerta del Mar
  • Girona, Spain, 17007
    • ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.
  • Madrid, Spain, 28033
    • Centro Oncologico MD Anderson International Espana
  • Manresa, Spain, 08243
    • ALTHAIA, Xarxa Assistencial Universitària de Manresa
  • Orense, Spain, 32005
    • Complejo Hospitalario Universitario de Orense
  • Sabadell, Spain, 08208
    • Corporacio Sanitaria Parc Tauli
  • Salamanca, Spain, 37007
    • Hospital Clinico Universitario de Salamanca
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia IVO
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • ALTHAIA, Xarxa Assistencial Universitària de Manresa
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07010
      • Hospital Universitari Son Espases
  • LA Coruna
    • Santiago de Compostela, LA Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago
• Sweden
  • Goteborg, Sweden, 413 45
    • Sahlgrenska Universitetssjukhuset, Sahlgrenska
  • Malmo, Sweden, 205 02
    • Skanes universitetssjukhus
  • Orebro, Sweden, 70 185
    • Universitetssjukhuset Örebro
  • Stockholm, Sweden, 118 83
    • Södersjukhuset AB
  • Stockholm, Sweden, 17176
    • Karolinska Universitetssjukhuset Solna
  • Umea, Sweden, 90 185
    • Norrlands universitetssjukhus
  • Umea, Sweden, 90185
    • Norrlands universitetssjukhus
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • University Hospitals Bristol NHS Foundation Trust
  • Glasgow, United Kingdom, G12 OYN
    • Beatson West of Scotland Cancer Centre
  • CITY OF Glasgow
    • Glasgow, CITY OF Glasgow, United Kingdom, G52 3NQ
      • Ross Hall Hospital
  • Devon
    • Wonford, Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon & Exeter Hospital
  • Greater London
    • London, Greater London, United Kingdom, NW3 2QG
      • Royal Free Hospital
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
  • WEST Midlands
    • Birmingham, WEST Midlands, United Kingdom, B15 2TH
      • Cancer Centre, Queen Elizabeth Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham, IDS Pharmacy
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Urological Institute dba Alaska Clinical Research Center
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Urological Associates of Southern Arizona, PC
  • California
    • Beverly Hills, California, United States, 90211
      • Tower Hematology Oncology Medical Group
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    • Los Angeles, California, United States, 90048
      • Cedars-Senai OCC Pharmacy
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center
    • Roseville, California, United States, 95661
      • Sutter Medical Group, Vascular & Varicose Vein Center
    • Roseville, California, United States, 95661
      • Sutter Medical Group
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center
    • Sacramento, California, United States, 95817
      • University of California, Davis, School of Medicine
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
    • Golden, Colorado, United States, 80401
      • Foothills Urology, P.C.
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology Oncology Associates
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Johns Hopkins Kimmel Cancer Center/ Sibley Infusion
  • Florida
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Health Hollis Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Investigational Drug Service
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology, PSC
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Hospital
    • Overland Park, Kansas, United States, 66211-1231
      • Kansas City Urology Care, PA
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center and Medical Pavilion
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center, Investigational Drug Services
    • Wichita, Kansas, United States, 67226
      • GU Research Network/Wichita Urology Group
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21287
      • John Hopkins University Hospital
    • Baltimore, Maryland, United States, 21287
      • The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Michigan
    • Macomb, Michigan, United States, 48044
      • Comprehensive Urology - Macomb Office
    • Royal Oak, Michigan, United States, 48067
      • Comprehensive Urology - Royal Oak (Stephenson) office
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • GU Research Network, LLC / Urology Cancer Center
  • Nevada
    • Fallon, Nevada, United States, 89406
      • VA Lahontan Valley Outpatient Clinic
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Cancer Center Basking Ridge
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Cancer Center Westchester
    • New York, New York, United States, 10065
      • Memorial Hospital
    • New York, New York, United States, 10065
      • Sidney Kimmel Center for Prostate and Urologic Cancers
    • Poughkeepsie, New York, United States, 12603
      • Premier Medical Group of the Hudson Valley PC
    • Rockville Centre, New York, United States, 11570
      • Memorial Sloan Kettering Cancer Center Rockville Centre
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of New York, PLLC
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Cancer Center Nassau
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke Investigational Chemotherapy Services
    • Durham, North Carolina, United States, 27710
      • Duke Nuclear Medicine
    • Greensboro, North Carolina, United States, 27403
      • Alliance Urology Specialists, PA
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • TriState urologic Services PSC Inc., dba The Urology Group
    • Cincinnati, Ohio, United States, 45236
      • Mercy Health Jewish Hospital
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
    • Middleburg Heights, Ohio, United States, 44130
      • Southwest Urology
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Medical Center Presbyterian Tower
    • Oklahoma City, Oklahoma, United States, 73140
      • Stephenson Cancer Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oregon Imaging Center
    • Springfield, Oregon, United States, 97477
      • Oregon Urology Institute
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of SE PA
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster Urology
    • Lancaster, Pennsylvania, United States, 17604
      • Keystone Urology Specialists
    • Philadelphia, Pennsylvania, United States, 19083
      • Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Medical Oncology
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Urology Associates
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital, Bodine Buiding
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University, Sidney Kimmel Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University, Medical Oncology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Unversity Medical Center, The Urology Clinic
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas, PLLC
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research
  • Virginia
    • Henrico, Virginia, United States, 23229
      • Henrico Doctor's Hospital
    • Richmond, Virginia, United States, 23235
      • Virginia Urology
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia, PLLC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
• Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
• PSA doubling time ≤ 9 months;
• Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
• Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).

Exclusion Criteria:

• Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
• Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before randomization is allowed.;
• Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
• Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
• Major surgery within 4 weeks before randomization;
• Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enzalutamide monotherapy; Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily	Drug: Enzalutamide; Other Names: Xtandi; MDV3100
Active Comparator: Leuprolide plus placebo; Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks. The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm, and patients continue to receive leuprolide alone.	Drug: Placebo (No longer applicable in Open Label study period); Sugar pill to mimic enzalutamide
Experimental: Enzalutamide plus leuprolide; Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks	Drug: Enzalutamide; Other Names: Xtandi; MDV3100; Drug: Leuprolide Open Label; Other Names: Lupron; Leuprorelin; Leuprolide Acetate; Eligard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide	MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first. Radiographic progression for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). Radiographic progression for bone disease was defined as the appearance of 1 or more metastatic lesions on bone scan (a bone scan assesses 5 regions of the skeleton, including skull, thorax, spine, pelvis, and extremities). Confirmation with a second imaging modality (plain film, computed tomography [CT], or magnetic resonance imaging [MRI]) was to be required when bone lesions were found in a single region on the bone scan. Appearance of metastatic lesions in 2 or more of the 5 regions on a bone scan was not to require confirmation with a second imaging modality.	From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastasis-free Survival (MFS) Compared Between Enzalutamide Monotherapy and Placebo Plus Leuprolide	MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first. Radiographic progression for soft tissue disease was defined by RECIST 1.1. Radiographic progression for bone disease was defined as the appearance of 1 or more metastatic lesions on bone scan (a bone scan assesses 5 regions of the skeleton, including skull, thorax, spine, pelvis, and extremities). Confirmation with a second imaging modality (plain film, CT, or MRI) was to be required when bone lesions were found in a single region on the bone scan. Appearance of metastatic lesions in 2 or more of the 5 regions on a bone scan was not to require confirmation with a second imaging modality.	From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Time to Prostate-specific Antigen (PSA) Progression	Time to PSA progression was defined as the time in months from randomization to the date of the first PSA value demonstrating progression, while participants were on study treatment, which was subsequently confirmed at least 3 weeks later. PSA progression date was defined as the date that a ≥25% increase and an absolute increase of ≥2 micrograms per liter (μg/L) (2 nanograms per milliliter [ng/mL]) above the nadir (or baseline for participants with no PSA decline by Week 25) that was confirmed by a second consecutive value at least 3 weeks later. For participants who had suspended treatment at Week 37 and later reinitiated treatment, baseline was reset as the last PSA assessment prior to or on the date of reinitiation of treatment.	From randomization until first PSA progression (up to Month 98)
Time to First Use of New Antineoplastic Therapy	Time to first use of new antineoplastic therapy was defined as the time in months from randomization to first use of new antineoplastic therapy for prostate cancer.	From randomization until first use of new antineoplastic therapy (up to Month 98)
Overall Survival (OS)	Overall survival was defined as the time in months between randomization and death due to any cause.	From randomization until death due to any cause (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Time to Distant Metastasis	The time to distant metastasis was defined as the time in months from randomization to the earliest objective evidence of distant soft tissue metastases or metastatic bone disease by blinded independent central review (BICR).	From randomization until the earliest objective evidence of distant soft tissue metastases or metastatic bone disease (up to Month 98)
Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) at 36 Weeks on Study Drug	Undetectable PSA at 36 weeks was serum PSA levels <0.2 ng/mL at Week 36. Percentage of participants with undetectable PSA at 36 weeks on study drug was calculated as the number of participants with undetectable PSA at Week 36 divided by the number of participants with PSA values at Week 36, and multiplied by 100.	At Week 36
Percentage of Participants Who Remained Treatment-free 2 Years After Suspension of Study Treatment at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)	Undetectable PSA at 36 weeks was serum PSA levels <0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. Percentage of participants who remained treatment-free 2 years after suspension of study treatment at Week 37 was calculated as the number of participants who remained treatment-free 2 years after suspension of study treatment at Week 37 divided by the number of participants with treatment suspension and multiplied by 100.	From randomization until 2 years after Week 37 (up to Month 34)
Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) 2 Years After Suspension of Treatment at Week 37 Due to Undetectable PSA	Undetectable PSA at 36 weeks was serum PSA levels <0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. Percentage of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA was calculated as the number of participants with undetectable PSA 2 years after suspension of treatment at Week 37 due to undetectable PSA divided by the number of participants with treatment suspension and multiplied by 100.	From randomization until 2 years after Week 37 (up to Month 34)
Time to Resumption of Any Hormonal Therapy Following Suspension at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)	Undetectable PSA at 36 weeks was serum PSA levels <0.2 ng/mL at Week 36. At Week 37, study treatment was suspended for participants whose PSA values were undetectable (<0.2 ng/mL) at Week 36 as determined by the central laboratory. Study treatment may have been suspended only once (at Week 37) due to undetectable PSA and was reinitiated if subsequent central laboratory PSA values increased to ≥2.0 ng/mL for participants with prior prostatectomy or ≥5.0 ng/mL for participants without prostatectomy. The time to resumption of any hormonal therapy following suspension at Week 37 due to undetectable PSA was defined as the time in months between the date of treatment suspension at Week 37 due to undetectable PSA and the date that hormonal therapy was restarted.	From treatment suspension at Week 37 until resumption of any hormonal therapy (up to Month 98)
Time to Castration Resistance	Time to castration resistance applied only to participants receiving leuprolide treatment and was defined as the time in months from randomization to the first occurrence of radiographic disease progression by BICR, PSA progression or symptomatic skeletal event (SSE) whichever occurred first with castrate levels of testosterone (<50 ng/dL).	From randomization to the first occurrence of radiographic disease progression, PSA progression or SSE, whichever occurred first with castrate levels of testosterone (up to Month 98)
Time to Symptomatic Progression	Time to symptomatic progression was defined as the time in months from randomization to development of a skeletal-related event, worsening of disease-related symptoms requiring initiation of a new antineoplastic therapy, or development of adverse events (AEs) and clinically significant signs and/or symptoms due to loco-regional tumor progression requiring opiate use, surgical intervention or radiation therapy, whichever occurred first.	From randomization until the first development of events defined as symptomatic progression (up to Month 98)
Time to First Symptomatic Skeletal Event (SSE)	Time to first symptomatic skeletal event was defined as the time in months from randomization to use of radiation therapy (external beam radiation therapy or radionuclides) or surgery to bone for prostate cancer, findings of clinically apparent pathologic bone fracture or of spinal cord compression, or new use of opiate and/or systemic antineoplastic therapy due to bone pain collected in the SSE case report form (CRF), whichever occurred first.	From randomization until the first development of events defined as SSE (up to Month 98)
Time From Randomization to Onset of Clinically Relevant Pain Progression, Defined as a 2-point or Greater Increase From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Question 3 Score	Time to clinically relevant pain progression was defined as the time from randomization to onset of pain progression, where clinically relevant pain progression was defined as a 2-point or greater increase from baseline in the BPI-SF question 3 score. BPI-SF is a self-administered questionnaire containing 9 main questions related to pain and analgesic medication use, where question 3 (paraphrased) is "On a scale of 0 [no pain] to 10 [pain as bad as you can imagine], please rate your pain at its worst in the last 24 hours" with higher score indicating worse pain.	From randomization until a 2-point or greater increase from baseline in the BPI-SF question 3 score (up to Month 98)
Time From Randomization to First Assessment With at Least a 10-point Decline (Deterioration) From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score	Time to first deterioration of the FACT-P total score was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score. FACT-P total score is based on subscale scores of physical, social/family, emotional, and functional well-being, as well as 12 site-specific items to assess prostate-related symptoms, ranging 0-156, with higher score representing better quality of life.	From randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score (up to Month 98)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (All-causality) During On-treatment Period, Modified Treatment Period, and Treatment Reinitiation Period - at PCD Cut-off Date of 31 January 2023	An AE was any untoward medical occurrence (eg, sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those events with onset dates occurring during the on-treatment period for the first time. On-treatment period was the time from the date of first dose of study treatment through a minimum of 30 days after last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day. Modified TEAEs (mTEAEs) were AEs that occurred during the modified treatment period (events occurring or worsening during the treatment suspension period after 30 days of last dose prior to treatment suspension were excluded). Reinitiated TEAEs (rTEAEs) were AEs that occurred with a start date during the dosing period after suspension and reinitiation of study treatment as defined by the reinitiation treatment period.	From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) (All-causality) - at PCD Cut-off Date of 31 January 2023	An AE was any untoward medical occurrence (e.g., sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those events with onset dates occurring during the on-treatment period for the first time. On-treatment period was defined as the time from the date of first dose of study treatment through a minimum of 30 days after last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day. The severity of all TEAEs was evaluated by the investigator based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life-threatening) and grade 5 (death related to AE).	From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Treatment-related) During On-treatment Period, Modified Treatment Period, and Treatment Reinitiation Period - at PCD Cut-off Date of 31 January 2023	An AE was any untoward medical occurrence (eg, sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those with onset dates occurring during the on-treatment period for the first time. On-treatment period was the time from date of first dose of study treatment through at least 30 days after last dose of study treatment or start day of new antineoplastic drug therapy minus 1 day. Treatment-related TEAEs were TEAEs attributed to study drug (enzalutamide, placebo or leuprolide). mTEAEs were AEs that occurred during the modified treatment period (events occurring or worsening during the treatment suspension period after 30 days of last dose prior to treatment suspension were excluded). rTEAEs were AEs that occurred with a start date during the dosing period after suspension and reinitiation of study treatment (reinitiation treatment period).	From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With SAEs (All-causality) During On-treatment Period, Modified Treatment Period and Treatment Reinitiation Period and SAEs (Treatment-related) During On-treatment period-at PCD Cut-off 31 Jan 2023	An AE was any untoward medical occurrence in a participant administered study drug/other protocol-imposed intervention regardless of attribution. SAEs were AEs resulting in any of the following outcomes/deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. On-treatment period was time from first dose date of study treatment through ≥30 days after last dose of study treatment or start day of new antineoplastic drug therapy -1 day. mSAEs were SAEs occurring during modified treatment period (events occurring/worsening during treatment suspension period after 30 days of last dose prior to treatment suspension were excluded). rSAEs were SAEs occurring with a start date during the dosing period after suspension and reinitiation of study treatment. Treatment-related SAEs were attributed to any study drug.	From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Enzalutamide or Placebo Discontinuation - at PCD Cut-off Date of 31 January 2023	An AE was any untoward medical occurrence (eg, sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. TEAEs were those events with onset dates occurring during the on-treatment period for the first time. On-treatment period was the time from the date of first dose of study treatment through a minimum of 30 days after last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day.	From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or Grade 4 Post-baseline in Hematology Laboratory Test Values - at PCD Cut-off Date of 31 January 2023	Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Hematology laboratory abnormalities were graded according to CTCAE version 4.03 (Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death). This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from ≤Grade 2 at baseline to Grade 3 and Grade 4 post-baseline for the following parameters: hemoglobin, leukocytes, lymphocytes, neutrophils, platelets.	From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or Grade 4 Post-baseline in Chemistry Laboratory Test Values - at PCD Cut-off Date of 31 January 2023	Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Chemistry laboratory abnormalities were graded according to CTCAE version 4.03 (Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death). This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from ≤Grade 2 at baseline to Grade 3 and Grade 4 post-baseline for the following parameters: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, calcium, creatine kinase, glucose, magnesium, phosphate, potassium, sodium.	From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Number of Participants With Potentially Clinically Significant Vital Signs - at PCD Cut-off Date of 31 January 2023	Participants with potentially clinically significant abnormalities in vital signs were summarized for the following parameters: systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR). Potentially clinically significant abnormalities were defined as (1) SBP (mmHg): >180 and increase from baseline >40; <90 and decrease from baseline >30; final visit or 2 consecutive visits change from baseline (CFB) ≥10, ≥15, ≥20; final visit or most extreme result ≥140, ≥180, ≥140 and ≥20 CFB, ≥180 and ≥20 CFB; (2) DBP (mmHg): >105 and increase from baseline >30; <50 and decrease from baseline >20; final visit or 2 consecutive visits CFB ≥5, ≥10, ≥15; final visit or most extreme result ≥90, ≥105, ≥90 and ≥15 CFB, ≥105 and ≥15 CFB; (3) HR (bpm): >120 and increase from baseline >30; <50 and decrease from baseline >20.	From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Astellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Investigators: Study Director: Pfizer Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Freedland SJ, De Giorgi U, Gleave M, Rosbrook B, Shen Q, Sugg J, Haas GP, Shore ND. A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design. BMJ Open. 2021 Aug 12;11(8):e046588. doi: 10.1136/bmjopen-2020-046588.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2014
• Primary Completion (Actual): January 31, 2023
• Study Completion (Estimated): September 19, 2026

Study Registration Dates

• First Submitted: December 14, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimated): December 18, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: MDV3100-13; C3431004 (Other Identifier: Alias Study Number); 2014-001634-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.