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
3 other identifiers
interventional
1,068
16 countries
221
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2014
Longer than P75 for phase_3
221 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2014
CompletedStudy Start
First participant enrolled
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedResults Posted
Study results publicly available
March 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2026
ExpectedJuly 8, 2025
July 1, 2025
8.1 years
December 14, 2014
January 31, 2024
July 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (22)
Metastasis-free Survival (MFS) Compared Between Enzalutamide Monotherapy and Placebo Plus Leuprolide
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
From randomization until first PSA progression (up to Month 98)
Time to First Use of New Antineoplastic Therapy
From randomization until first use of new antineoplastic therapy (up to Month 98)
Overall Survival (OS)
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
From randomization until the earliest objective evidence of distant soft tissue metastases or metastatic bone disease (up to Month 98)
- +17 more secondary outcomes
Study Arms (3)
Enzalutamide plus leuprolide
EXPERIMENTALEnzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks
Enzalutamide monotherapy
EXPERIMENTALEnzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
Leuprolide plus placebo
ACTIVE COMPARATOREnzalutamide 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.
Interventions
Sugar pill to mimic enzalutamide
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Astellas Pharma Inccollaborator
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.collaborator
Study Sites (247)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, 99503, United States
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211, United States
Cedars-Senai OCC Pharmacy
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
Sutter Medical Group, Vascular & Varicose Vein Center
Roseville, California, 95661, United States
Sutter Medical Group
Roseville, California, 95661, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of California, Davis, School of Medicine
Sacramento, California, 95817, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Foothills Urology, P.C.
Golden, Colorado, 80401, United States
Eastern Connecticut Hematology Oncology Associates
Norwich, Connecticut, 06360, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
First Urology, PSC
Jeffersonville, Indiana, 47130, United States
The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Kansas City Urology Care, PA
Overland Park, Kansas, 66211, United States
The University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205, United States
GU Research Network/Wichita Urology Group
Wichita, Kansas, 67226, United States
John Hopkins University Hospital
Baltimore, Maryland, 21287, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services
Baltimore, Maryland, 21287, United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204, United States
Comprehensive Urology - Macomb Office
Macomb, Michigan, 48044, United States
Comprehensive Urology - Royal Oak (Stephenson) office
Royal Oak, Michigan, 48067, United States
GU Research Network, LLC / Urology Cancer Center
Omaha, Nebraska, 68130, United States
VA Lahontan Valley Outpatient Clinic
Fallon, Nevada, 89406, United States
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center Westchester
Harrison, New York, 10604, United States
Memorial Hospital
New York, New York, 10065, United States
Sidney Kimmel Center for Prostate and Urologic Cancers
New York, New York, 10065, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12603, United States
Memorial Sloan Kettering Cancer Center Rockville Centre
Rockville Centre, New York, 11570, United States
Associated Medical Professionals of New York, PLLC
Syracuse, New York, 13210, United States
Memorial Sloan Kettering Cancer Center Nassau
Uniondale, New York, 11553, United States
Duke Investigational Chemotherapy Services
Durham, North Carolina, 27710, United States
Duke Nuclear Medicine
Durham, North Carolina, 27710, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Alliance Urology Specialists, PA
Greensboro, North Carolina, 27403, United States
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, 45212, United States
Mercy Health Jewish Hospital
Cincinnati, Ohio, 45236, United States
Clinical Research Solutions
Middleburg Heights, Ohio, 44130, United States
Southwest Urology
Middleburg Heights, Ohio, 44130, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Imaging Center
Eugene, Oregon, 97401, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, 19083, United States
Honickman Centre
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital, Bodine Buiding
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University, Medical Oncology
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery
Nashville, Tennessee, 37232, United States
Vanderbilt Unversity Medical Center, The Urology Clinic
Nashville, Tennessee, 37232, United States
Urology Clinics of North Texas, PLLC
Dallas, Texas, 75231, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Henrico Doctor's Hospital
Henrico, Virginia, 23229, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Urology of Virginia, PLLC.
Virginia Beach, Virginia, 23462, United States
Genesis Cancer Care NSW
Gateshead, New South Wales, 2290, Australia
Lismore Base hospital
Lismore, New South Wales, 2480, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Macquarie University
North Ryde, New South Wales, 2109, Australia
Genesis Cancer Care
North Sydney, New South Wales, 2060, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
GenesisCare North Shore
St Leonards, New South Wales, 2065, Australia
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Australian Clinical Trials Pty Ltd
Wahroonga, New South Wales, 2076, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Illawarra Cancer Care Centre
Wollongong, New South Wales, 2500, Australia
Crown Princess Mary Cancer Centre
Westmead, NEW, 2145, Australia
Icon Cancer Care Wesley
Auchenflower, Queensland, 4066, Australia
Icon Cancer Care Chermside
Chermside, Queensland, 4032, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
Icon Cancer Foundation
South Brisbane, Queensland, 4101, Australia
Icon Cancer Centre Southport
Southport, Queensland, 4215, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Australian Urology Associates
Malvern, Victoria, 3144, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Hospital Barmherzige Schwestern Linz
Linz, Upper Austria, 4010, Austria
Hospital Barmherzige Schwestern Linz, Department of Urology
Linz, 4010, Austria
Ordensklinikum Linz GmbH
Linz, 4020, Austria
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria
Salzburg, 5020, Austria
Department of Radiology, University Hospital Salzburg, Austria
Salzburg, 5020, Austria
Department of Urology,Paracelsus Medical University Salzburg
Salzburg, 5020, Austria
AKH - Medizinische Universität Wien
Vienna, 1090, Austria
Department of Internal Medicine I, Medical university Vienna
Vienna, 1090, Austria
Hospital São Rafael S.A
Salvador, Estado de Bahia, 41253-190, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-0000, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
Campinas, São Paulo, 13083-970, Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda
Ijuí/RS, 98700-000, Brazil
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Manitoba Prostate Centre CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
The Male/Female Health and Research Centre, Royal Court Medical Centre
Barrie, Ontario, L4M 7G1, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7, Canada
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
Urology Associates/ Urologic Medical Research
Kitchener, Ontario, N2N 2B9, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Ultra-Med Inc.
Pointe-Claire, Quebec, H9R 4S3, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO
Québec, Quebec, G1R 3S1, Canada
Rigshospitalet - Copenhagen University Hospital
Copenhagen N, Copenhagen N, 2200, Denmark
Aarhus University Hospital
Arhus N, 8200, Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100, Denmark
Rigshospitalet, Dept of Radiology
Copenhagen, 2100, Denmark
Odense University Hospital
Odense C, 5000, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Helsingin yliopistollinen keskussairaala
Helsinki, 00290, Finland
Oulun yliopistollinen sairaala
Oulu, 90220, Finland
Satakunnan Keskussairaala
Pori, 28500, Finland
Seinaejoen Keskussairaala
Seinäjoki, 60220, Finland
Tampereen yliopistollinen sairaala
Tampere, 33520, Finland
ICO- site Paul Papin
Angers, 49933, France
Clinique Pasteur - Lanroze Service Pharmacie
Brest, 29200, France
Clinique Pasteur - Lanroze
Brest, 29200, France
CHD Vendée
La Roche-sur-Yon, 85925, France
CHRU de Lille - Hopital Claude Huriez
Lille, 59037, France
ICM Val d'Aurelle
Montpellier, 34298, France
CHU de Nantes - Hotel Dieu
Nantes, 44000, France
Hopital Saint-Louis
Paris, 75475, France
Institut Mutualiste Montsouris
Paris, 75674, France
CHP Saint-Gregoire
Saint-Grégoire, 35760, France
ICO - site Rene Gauducheau
Saint-Herblain, 44805, France
Hia Begin
Saint-Mandé, 94160, France
Hopital Foch
Suresnes, 92151, France
Institut Gustave Roussy
Villejuif, 94800, France
Institut Gustave Roussy
Villejuif, 94805, France
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
UO di Oncologia,Ospedale Civile degli Infermi
Faenza RA, 48018, Italy
UO di Radiologia, Ospedale Civile degli Infermi
Faenza RA, 48018, Italy
UO di Oncologia, Ospedale Civile Umberto I
Lugo RA, 48022, Italy
Uo di Radiologia, Ospedale Civile Umberto I
Lugo RA, 48022, Italy
Laboratorio Farmaci Antiblastici, IRCCS Istituto
Meldola (FC), 47014, Italy
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC), 47014, Italy
UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)
Meldola (FC), 47014, Italy
Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A
Napoli, 80131, Italy
S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga
Orbassano (TO), 10043, Italy
S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga
Orbassano (TO), 10043, Italy
Servizio di Farmacia, Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
Servizio di Radiologia, Ospedale Santa Maria Delle Croci
Ravenna, 48121, Italy
UO di Oncologia Medica, Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
Farmacia Interna, Ospedale degli Infermi
Rimini, 47923, Italy
UO Oncologia, Ospedale degli Infermi
Rimini, 47923, Italy
Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani
Roma, 00152, Italy
U.O. di Oncologia Medica, Ospedale Santa Chiara
Trento, 38122, Italy
U.O. Medicina Nucleare, Ospedale Santa Chiara
Trento, 38122, Italy
U.O. Radiologia, Ospedale Santa Chiara
Trento, 38122, Italy
VU Medical Centrum, Department of Urology
Amsterdam, 1081 HV, Netherlands
Academisch Medisch Centrum
Amsterdam, 1105AZ, Netherlands
Gelderse Vallei Ziekenhuis
Ede, 6710 HN, Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, 5623 EJ, Netherlands
University Medical Centrum Groningen, Department Urologie
Groningen, 9713 GZ, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Maastricht University Medical Center, Department of Urology
Maastricht, 6229 HX, Netherlands
Antonius Ziekenhuis
Sneek, 8601 ZK, Netherlands
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
Gdansk, 80-952, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.
Słupsk, 76-200, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny
Słupsk, 76-200, Poland
Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
Torun, 87-100, Poland
Centrum Medyczne Melita Medical
Wroclaw, 50-449, Poland
EMC Instytut Medyczny Spolka Akcyjna
Wroclaw, 54-144, Poland
Fakultna nemocnica s poliklinikou F.D.Roosevelta
Banská Bystrica, 975 17, Slovakia
CUIMED, s.r.o., Urologicka ambulancia
Bratislava, 851 05, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Košice, 041 91, Slovakia
Univerzitna nemocnica Martin
Martin, 036 59, Slovakia
UROEXAM, spol. s r.o.
Nitra, 949 01, Slovakia
MILAB
Prešov, 080 81, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, 012 07, Slovakia
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 58128, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Severance Hospital. Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07010, Spain
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, LA Coruna, 15706, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio
Barcelona, 08036, Spain
Hospital Universitario Puerta del Mar
Cadiz, 11009, Spain
ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia
Girona, 17007, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.
Madrid, 28007, Spain
Centro Oncologico MD Anderson International Espana
Madrid, 28033, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Complejo Hospitalario Universitario de Orense
Ourense, 32005, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, 08208, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Instituto Valenciano de Oncologia IVO
Valencia, 46009, Spain
Sahlgrenska Universitetssjukhuset, Sahlgrenska
Gothenburg, 413 45, Sweden
Skanes Universitetssjukhus
Malmo, 205 02, Sweden
Universitetssjukhuset Orebro
Örebro, 70 185, Sweden
Sodersjukhuset AB
Stockholm, 118 83, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 17176, Sweden
Norrlands Universitetssjukhus
Umeå, 90 185, Sweden
Norrlands Universitetssjukhus
Umeå, 90185, Sweden
Akademiska Sjukhuset
Uppsala, 751 85, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 333, Taiwan
Ross Hall Hospital
Glasgow, CITY of Glasgow, G52 3NQ, United Kingdom
Royal Devon & Exeter Hospital
Wonford, Devon, EX2 5DW, United Kingdom
Royal Free Hospital
London, Greater London, NW3 2QG, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
Cancer Centre, Queen Elizabeth Hospital
Birmingham, WEST Midlands, B15 2TH, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 OYN, United Kingdom
Related Publications (8)
Shore ND, Gleave M, De Giorgi U, Rannikko A, Pieczonka CM, Sridharan S, Brasso K, Woo HH, Gomez Caamano A, Saranchuk JW, Nordquist LT, Ferreira U, Tang Y, Rosbrook B, Haas GP, Rosales M, Zohren F, Tarazi J, Freedland SJ. Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary Endpoints From the EMBARK Trial. J Urol. 2025 Dec 9:101097JU0000000000004890. doi: 10.1097/JU.0000000000004890. Online ahead of print.
PMID: 41364813DERIVEDShore ND, De Giorgi U, Tutrone RF, Bailen JL, Roos EPM, Kliment J, Marx G, Karsh LI, Ramirez-Backhaus M, Uchio EM, Supiot S, Tang Y, Rosbrook B, Haas GP, Rosales M, Zohren F, Tarazi J, Freedland SJ. Enzalutamide Monotherapy for the Treatment of Prostate Cancer With High-Risk Biochemical Recurrence: EMBARK Secondary End Points. J Urol. 2025 Dec 17:101097JU0000000000004879. doi: 10.1097/JU.0000000000004879. Online ahead of print.
PMID: 41349040DERIVEDShore ND, Luz MA, De Giorgi U, Gleave M, Gotto GT, Pieczonka CM, Haas GP, Kim CS, Ramirez-Backhaus M, Rannikko A, Kalac M, Sridharan S, Rosales M, Tang Y, Tutrone RF Jr, Venugopal B, Villers A, Woo HH, Wang F, Freedland SJ. Improved Survival with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2025 Oct 19. doi: 10.1056/NEJMoa2510310. Online ahead of print.
PMID: 41124201DERIVEDDe Giorgi U, Freedland SJ, Rannikko A, Ramirez-Backhaus M, Villers A, Tarazi J, Tang Y, Haas GP, Rosales M, Shore ND. Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK. Prostate Cancer Prostatic Dis. 2025 Mar 26. doi: 10.1038/s41391-025-00959-8. Online ahead of print.
PMID: 40140551DERIVEDFreedland SJ, Gleave M, De Giorgi U, Rannikko A, Pieczonka CM, Tutrone RF, Venugopal B, Woo HH, Ramirez-Backhaus M, Supiot S, Lantz A, Ganguli A, Ivanova J, Kral P, Huang SP, Saad F, Shore ND. Enzalutamide and Quality of Life in Biochemically Recurrent Prostate Cancer. NEJM Evid. 2023 Dec;2(12):EVIDoa2300251. doi: 10.1056/EVIDoa2300251. Epub 2023 Oct 22.
PMID: 38320501DERIVEDFreedland SJ, de Almeida Luz M, De Giorgi U, Gleave M, Gotto GT, Pieczonka CM, Haas GP, Kim CS, Ramirez-Backhaus M, Rannikko A, Tarazi J, Sridharan S, Sugg J, Tang Y, Tutrone RF Jr, Venugopal B, Villers A, Woo HH, Zohren F, Shore ND; EMBARK Study. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2023 Oct 19;389(16):1453-1465. doi: 10.1056/NEJMoa2303974.
PMID: 37851874DERIVEDLBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer. J Urol. 2023 Jul;210(1):224-226. doi: 10.1097/JU.0000000000003518. Epub 2023 May 2.
PMID: 37119051DERIVEDFreedland 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.
PMID: 34385241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The randomized blinded portion of the study has concluded. The study is now being conducted open label manner.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2014
First Posted
December 18, 2014
Study Start
December 17, 2014
Primary Completion
January 31, 2023
Study Completion (Estimated)
September 19, 2026
Last Updated
July 8, 2025
Results First Posted
March 25, 2024
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
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.