Hormone Sensitive Prostate CancerPhase 3NCT02319837
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
A Phase 3 study testing Enzalutamide and Leuprolide Open Label in people with Hormone Sensitive Prostate Cancer and Prostate Cancer, run by Pfizer at 255 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- What is being tested?
- Enzalutamide and Leuprolide Open Label
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,068 participants
- Where
- 255 sitesin 17 countries
- Study dates
- 17 Dec 2014to 19 Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
255 sites in 17 countries.
255 sites in 17 countries
United States77 sites
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, 99503
Emory University Hospital
Atlanta, Georgia, 30322
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30329
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004
John Hopkins University Hospital
Baltimore, Maryland, 21287
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services
Baltimore, Maryland, 21287
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, 35294
Northwestern Medical Group
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, 45212
Mercy Health Jewish Hospital
Cincinnati, Ohio, 45236
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, 11725
Urology Clinics of North Texas, PLLC
Dallas, Texas, 75231
The Urology Center of Colorado
Denver, Colorado, 80211
Duke Investigational Chemotherapy Services
Durham, North Carolina, 27710
Duke Nuclear Medicine
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
Oregon Imaging Center
Eugene, Oregon, 97401
VA Lahontan Valley Outpatient Clinic
Fallon, Nevada, 89406
Vanderbilt Urology Clinic Cool Springs
Franklin, Tennessee, 37067
Foothills Urology, P.C.
Golden, Colorado, 80401
Alliance Urology Specialists, PA
Greensboro, North Carolina, 27403
Memorial Sloan Kettering Cancer Center Westchester
Harrison, New York, 10604
Henrico Doctor's Hospital
Henrico, Virginia, 23229
Houston Metro Urology
Houston, Texas, 77027
First Urology, PSC
Jeffersonville, Indiana, 47130
The University of Kansas Hospital
Kansas City, Kansas, 66160
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
Cedars-Senai OCC Pharmacy
Los Angeles, California, 90048
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Comprehensive Urology - Macomb Office
Macomb, Michigan, 48044
Clinical Research Solutions
Middleburg Heights, Ohio, 44130
Southwest Urology
Middleburg Heights, Ohio, 44130
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Vanderbilt Health Belle Meade
Nashville, Tennessee, 37205
The Vanderbilt Clinic, Department of Urology
Nashville, Tennessee, 37232
Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery
Nashville, Tennessee, 37232
Memorial Hospital
New York, New York, 10065
Sidney Kimmel Center for Prostate and Urologic Cancers
New York, New York, 10065
Eastern Connecticut Hematology Oncology Associates
Norwich, Connecticut, 06360
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
GU Research Network, LLC / Urology Cancer Center
Omaha, Nebraska, 68130
University of California, Irvine Medical Center
Orange, California, 92868
Kansas City Urology Care, PA
Overland Park, Kansas, 66211
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, 19083
Honickman Centre
Philadelphia, Pennsylvania, 19107
Jefferson Medical Oncology
Philadelphia, Pennsylvania, 19107
Jefferson Urology Associates
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Hospital, Bodine Building
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University, Medical Oncology
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12603
Virginia Urology
Richmond, Virginia, 23235
Memorial Sloan Kettering Cancer Center Rockville Centre
Rockville Centre, New York, 11570
Sutter Medical Group, Vascular & Varicose Vein Center
Roseville, California, 95661
Sutter Medical Group
Roseville, California, 95661
Comprehensive Urology - Royal Oak (Stephenson) office
Royal Oak, Michigan, 48067
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
University of California Davis Medical Center
Sacramento, California, 95817
University of California, Davis, School of Medicine
Sacramento, California, 95817
Urology San Antonio Research
San Antonio, Texas, 78229
Oregon Urology Institute
Springfield, Oregon, 97477
Associated Medical Professionals of New York, PLLC
Syracuse, New York, 13210
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Arizona Urology Specialists
Tucson, Arizona, 85741
Memorial Sloan Kettering Cancer Center Nassau
Uniondale, New York, 11553
Urology of Virginia, PLLC.
Virginia Beach, Virginia, 23462
The University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205
GU Research Network/Wichita Urology Group
Wichita, Kansas, 67226
Australia26 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Icon Cancer Care Wesley
Auchenflower, Queensland, 4066
Box Hill Hospital
Box Hill, Victoria, 3128
Icon Cancer Care Chermside
Chermside, Queensland, 4032
Monash Medical Centre
Clayton, Victoria, 3168
Genesis Cancer Care NSW
Gateshead, New South Wales, 2290
Austin Health
Heidelberg, Victoria, 3084
Lismore Base hospital
Lismore, New South Wales, 2480
Liverpool Hospital
Liverpool, New South Wales, 2170
Australian Urology Associates
Malvern, Victoria, 3144
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Macquarie University
North Ryde, New South Wales, 2109
Genesis Cancer Care
North Sydney, New South Wales, 2060
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101
Icon Cancer Foundation
South Brisbane, Queensland, 4101
Icon Cancer Centre Southport
Southport, Queensland, 4215
Sunshine Hospital
St Albans, Victoria, 3021
GenesisCare North Shore
St Leonards, New South Wales, 2065
The Tweed Hospital
Tweed Heads, New South Wales, 2485
Australian Clinical Trials Pty Ltd
Wahroonga, New South Wales, 2076
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Westmead Hospital
Westmead, New South Wales, 2145
Crown Princess Mary Cancer Centre
Westmead, NEW, 2145
Illawarra Cancer Care Centre
Wollongong, New South Wales, 2500
Italy23 sites
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
UO di Oncologia,Ospedale Civile degli Infermi
Faenza RA, 48018
UO di Radiologia, Ospedale Civile degli Infermi
Faenza RA, 48018
UO di Oncologia, Ospedale Civile Umberto I
Lugo RA, 48022
Uo di Radiologia, Ospedale Civile Umberto I
Lugo RA, 48022
Laboratorio Farmaci Antiblastici, IRCCS Istituto
Meldola (FC), 47014
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC), 47014
UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)
Meldola (FC), 47014
Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A
Naples, 80131
S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga
Orbassano (TO), 10043
S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga
Orbassano (TO), 10043
Servizio di Farmacia, Ospedale Santa Maria delle Croci
Ravenna, 48121
Servizio di Radiologia, Ospedale Santa Maria Delle Croci
Ravenna, 48121
UO di Oncologia Medica, Ospedale Santa Maria delle Croci
Ravenna, 48121
Farmacia Interna, Ospedale degli Infermi
Rimini, 47923
UO Oncologia, Ospedale degli Infermi
Rimini, 47923
Dipartimento di Oncologia Medica - Ospedale San Camillo Forlanini
Roma, ROME, 00152
Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani
Roma, 00152
U.O. di Oncologia Medica, Ospedale Santa Chiara
Trento, 38122
U.O. Medicina Nucleare, Ospedale Santa Chiara
Trento, 38122
U.O. Radiologia, Ospedale Santa Chiara
Trento, 38122
Canada19 sites
The Male/Female Health and Research Centre, Royal Court Medical Centre
Barrie, Ontario, L4M 7G1
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3
Nova Scotia Heath Authority, Central
Halifax, Nova Scotia, B3H 2Y9
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
Urology Associates/ Urologic Medical Research
Kitchener, Ontario, N2N 2B9
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Ultra-Med Inc.
Pointe-Claire, Quebec, H9R 4S3
CHU de Quebec - L'Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO
Québec, Quebec, G1R 3S1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9
Manitoba Prostate Centre CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Spain16 sites
Hospital del Mar
Barcelona, 08003
Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio
Barcelona, 08036
Hospital Universitario Puerta del Mar
Cadiz, 11009
ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia
Girona, 17007
Hospital Universitario de La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.
Madrid, 28007
Centro Oncologico MD Anderson International Espana
Madrid, 28033
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
Complejo Hospitalario Universitario de Orense
Ourense, 32005
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07010
Corporacio Sanitaria Parc Tauli
Sabadell, 08208
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, LA Coruna, 15706
Instituto Valenciano de Oncologia IVO
Valencia, 46009
France15 sites
ICO- site Paul Papin
Angers, 49933
Clinique Pasteur - Lanroze Service Pharmacie
Brest, 29200
Clinique Pasteur - Lanroze
Brest, 29200
CHD Vendée
La Roche-sur-Yon, 85925
CHRU de Lille - Hopital Claude Huriez
Lille, 59037
ICM Val d'Aurelle
Montpellier, 34298
CHU de Nantes - Hotel Dieu
Nantes, 44000
Hopital Saint-Louis
Paris, 75475
Institut Mutualiste Montsouris
Paris, 75674
CHP Saint-Gregoire
Saint-Grégoire, 35760
ICO - site Rene Gauducheau
Saint-Herblain, 44805
Hia Begin
Saint-Mandé, 94160
Hopital Foch
Suresnes, 92151
Institut Gustave Roussy
Villejuif, 94800
Institut Gustave Roussy
Villejuif, 94805
Brazil10 sites
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
Campinas, São Paulo, 13083-970
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda
Ijuí/ RS, 98700-000
CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
Porto Alegre, Rio Grande do Sul, 90430-090
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital São Rafael S.A
Salvador, Estado de Bahia, 41253-190
Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo André, São Paulo, 09051-040
Austria9 sites
Hospital Barmherzige Schwestern Linz, Department of Urology and Andrology
Linz, Other, 4020
Hospital Barmherzige Schwestern Linz
Linz, Upper Austria, 4010
Ordensklinikum Linz, Barmherzige Schwestern
Linz, Upper Austria, 4010
Ordensklinikum Linz GmbH
Linz, 4020
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria
Salzburg, 5020
Department of Radiology, University Hospital Salzburg, Austria
Salzburg, 5020
Department of Urology,Paracelsus Medical University Salzburg
Salzburg, 5020
AKH - Medizinische Universität Wien
Vienna, 1090
Department of Internal Medicine I, Medical university Vienna
Vienna, 1090
Netherlands8 sites
VU Medical Centrum, Department of Urology
Amsterdam, 1081 HV
Academisch Medisch Centrum
Amsterdam, 1105AZ
Gelderse Vallei Ziekenhuis
Ede, 6710 HN
Catharina Ziekenhuis Eindhoven
Eindhoven, 5623 EJ
University Medical Centrum Groningen, Department Urologie
Groningen, 9713 GZ
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
Maastricht University Medical Center, Department of Urology
Maastricht, 6229 HX
Antonius Ziekenhuis
Sneek, 8601 ZK
South Korea8 sites
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 58128
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Severance Hospital. Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Samsung Medical Center
Seoul, 06351
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Sweden8 sites
Sahlgrenska Universitetssjukhuset, Sahlgrenska
Gothenburg, 413 45
Skanes Universitetssjukhus
Malmö, 205 02
Universitetssjukhuset Orebro
Örebro, 70 185
Sodersjukhuset AB
Stockholm, 118 83
Karolinska Universitetssjukhuset Solna
Stockholm, 17176
Norrlands Universitetssjukhus
Umeå, 90 185
Norrlands Universitetssjukhus
Umeå, 90185
Akademiska sjukhuset
Uppsala, 751 85
Slovakia7 sites
Fakultna nemocnica s poliklinikou F.D.Roosevelta
Banská Bystrica, 975 17
CUIMED, s.r.o., Urologicka ambulancia
Bratislava, 851 05
Vychodoslovensky onkologicky ustav, a.s.
Košice, 041 91
Univerzitna nemocnica Martin
Martin, 036 59
UROEXAM, spol. s r.o.
Nitra, 949 01
MILAB
Prešov, 080 81
Fakultna nemocnica s poliklinikou Zilina
Žilina, 012 07
United Kingdom7 sites
Cancer Centre, Queen Elizabeth Hospital
Birmingham, WEST Midlands, B15 2TH
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED
Ross Hall Hospital
Glasgow, CITY of Glasgow, G52 3NQ
Beatson West of Scotland Cancer Centre
Glasgow, G12 OYN
Royal Free Hospital
London, Greater London, NW3 2QG
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Royal Devon & Exeter Hospital
Wonford, Devon, EX2 5DW
Denmark6 sites
Aarhus University Hospital
Arhus N, 8200
Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100
Rigshospitalet, Dept of Radiology
Copenhagen, 2100
Rigshospitalet - Copenhagen University Hospital
Copenhagen N, Other, 2200
Odense University Hospital
Odense C, 5000
Vejle Sygehus
Vejle, 7100
Poland6 sites
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
Gdansk, 80-952
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.
Słupsk, 76-200
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny
Słupsk, 76-200
Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
Torun, 87-100
Penta Hospitals Przychodnie
Wroclaw, Other, 54-239
Centrum Medyczne Melita Medical
Wroclaw, 50-449
Finland5 sites
Helsingin yliopistollinen keskussairaala
Helsinki, 00290
Oulun yliopistollinen sairaala
Oulu, 90220
Satakunnan Keskussairaala
Pori, 28500
Seinaejoen Keskussairaala
Seinäjoki, 60220
Tampereen yliopistollinen sairaala
Tampere, 33520
Taiwan5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 10002
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
About this study
Official title: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
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.
- Being tested
- Enzalutamide, Placebo (No longer applicable in Open Label study period), Leuprolide Open Label
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called MDV3100, Xtandi
Placebo (No longer applicable in Open Label study period)Drug
Sugar pill to mimic enzalutamide
Leuprolide Open LabelDrug
Also called Eligard, Leuprolide Acetate, Leuprorelin, Lupron
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide plus leuprolide | Experimental | Enzalutamide (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 Receives: Drug: Enzalutamide; Drug: Leuprolide Open Label |
| Enzalutamide monotherapy | Experimental | Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily Receives: Drug: Enzalutamide |
| Leuprolide plus placebo | Active comparator | 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. Receives: Drug: Placebo (No longer applicable in Open Label study period) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study start17 Dec 2014
- Primary completion31 Jan 2023
- Study completion19 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hormone Sensitive Prostate CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319837
- Sponsor's protocol ID
- MDV3100-13
- Other IDs
- C3431004, 2024-513521-23-00
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2014
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
Freedland SJ, De Giorgi U. Enzalutamide in biochemically recurrent prostate cancer: key findings from subsequent analyses of EMBARK and their implications in clinical practice. Future Oncol. 2026 Jun;22(14):1593-1600. doi: 10.1080/14796694.2026.2676559. Epub 2026 Jun 23.
PubMed 42333826Shore 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 End Points From the EMBARK Trial. J Urol. 2026 May;215(5):512-525. doi: 10.1097/JU.0000000000004890. Epub 2025 Dec 9.
PubMed 41364813Shore 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. 2026 Apr;215(4):396-407. doi: 10.1097/JU.0000000000004879. Epub 2025 Dec 5.
PubMed 41349040Shore 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. 2026 Feb 5;394(6):563-575. doi: 10.1056/NEJMoa2510310. Epub 2025 Oct 19.
PubMed 41124201De 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. 2026 Mar;29(1):198-201. doi: 10.1038/s41391-025-00959-8. Epub 2025 Mar 26.
PubMed 40140551Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.
PubMed 38421252Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.
PubMed 38421243Freedland 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.
PubMed 38320501Freedland 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.
PubMed 37851874LBA02-09 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.
PubMed 37119051Freedland 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.
PubMed 34385241