1,251
Participants
Start Date
February 12, 2020
Primary Completion Date
October 31, 2022
Study Completion Date
February 2, 2026
Pembrolizumab
Pembrolizumab is administered as an IV infusion at 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
Enzalutamide
Enzalutamide is administered orally as capsules/tablets at a dosage of 160 mg daily. Enzalutamide is administered continuously until criteria for discontinuation are met.
Androgen Deprivation Therapy (ADT)
Stable regimen of ADT (LHRH agonist or antagonist) at a dose and frequency of administration that is consistent with the local product label.
Placebo
Placebo infusion solution is administered as an IV infusion on Day 1 of each 21-day cycle for up to 35 cycles.
National Taiwan University Hospital ( Site 0500), Taipei
CHUV (centre hospitalier universitaire vaudois) ( Site 2002), Lausanne
Krankenhaus der Barmherzigen Brüder Wien ( Site 0904), Vienna
Auckland City Hospital ( Site 0321), Auckland
Medizinische Universität Wien ( Site 0903), Vienna
Chris OBrien Lifehouse ( Site 0300), Camperdown
Rigshospitalet ( Site 1005), Copenhagen
Port Macquarie Base Hospital ( Site 0301), Port Macquarie
Riverina Cancer Care Center ( Site 0302), Wagga Wagga
Herlev og Gentofte Hospital. ( Site 1004), Herlev
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0306), Melbourne
Box Hill Hospital ( Site 0304), Box Hill
Monash Health ( Site 0305), Clayton
Ordensklinikum Linz GmbH Elisabethinen ( Site 0901), Linz
Gallipoli Medical Research Ltd ( Site 0309), Greenslopes
John Flynn Hospital & Medical Centre ( Site 0308), Tugun
Odense Universitetshospital ( Site 1003), Odense
Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 0900), Salzburg
Fiona Stanley Hospital ( Site 0311), Perth
Kantonsspital Graubuenden ( Site 2003), Chur
Vejle Sygehus ( Site 1002), Vejle
Universitaetsspital Zuerich ( Site 2001), Zurich
Aalborg Universitetshospital ( Site 1000), Aalborg
Kantonsspital St. Gallen ( Site 2000), Sankt Gallen
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0270), New York
Weill Cornell Medical College ( Site 0263), New York
Charite Universitaetsmedizin Berlin ( Site 1201), Berlin
Chulalongkorn Hospital, Medical Oncology Unit ( Site 0600), Bangkok
Ramathibodi Hospital. ( Site 0601), Bangkok
National Cancer Center ( Site 0400), Gyeonggi-do
Faculty of Medicine Siriraj Hospital ( Site 0602), Bangkok
Taipei Veterans General Hospital ( Site 0501), Taipei
Clinica Peruano Americana S.A. ( Site 2702), Trujillo
Associated Medical Professionals of NY ( Site 0251), Syracuse
Seoul National University Bundang Hospital ( Site 0401), Seongnam-si
Hospital Nacional Guillermo Almenara Irigoyen ( Site 2708), Lima
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 2706), Lima
Hospital Militar Central [Lima, Peru] ( Site 2704), Lima
Institut Català d'Oncologia (ICO) - Girona ( Site 1900), Girona
MidLantic Urology ( Site 0273), Bala-Cynwyd
Sibley Memorial Hospital ( Site 0275), Washington D.C.
Istituto Clinico Humanitas Research Hospital ( Site 1500), Rozzano
Istituto Nazionale dei Tumori ( Site 1510), Milan
Universitaetsklinikum Hamburg-Eppendorf ( Site 1212), Hamburg
TYKS T-sairaala Syopatautien pkl ( Site 1019), Turku
Centre Georges Francois Leclerc ( Site 1112), Dijon
The Sidney Kimmel Comprehensive Cancer Center ( Site 0204), Baltimore
Inova Health System ( Site 0205), Fairfax
Urology of Virginia ( Site 0224), Virginia Beach
CHU-Jean Minjoz ( Site 1101), Besançon
Hospital Universitario Lucus Augusti ( Site 1905), Lugo
Duke University ( Site 0206), Durham
Hospital Universitario Ramon y Cajal ( Site 1902), Madrid
Hospital Clinico San Carlos ( Site 1906), Madrid
Hospital 12 de Octubre de Madrid ( Site 1903), Madrid
Hospital San Lucas Cardiologica del Sureste ( Site 2606), Tuxtla Gutiérrez
CHU de Brest -Site Hopital Morvan ( Site 1103), Brest
Ralph H. Johnson VA Center ( Site 0256), Charleston
Carolina Urologic Research Center ( Site 0259), Myrtle Beach
Centro Estatal de Cancerologia de Chihuahua ( Site 2608), Chihuahua City
Institut Bergonie ( Site 1104), Bordeaux
Centro Di Riferimento Oncologico ( Site 1511), Aviano
Chang Gung Medical Foundation. Linkou ( Site 0502), Taoyuan District
Tampereen yliopistollinen sairaala ( Site 1022), Tampere
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2100), Istanbul
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 1117), Rennes
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 2102), Izmir
A.O. Verona-Ospedale Civile Maggiore Borgo-Trento ( Site 1504), Verona
Urology Associates [Nashville, TN] ( Site 0233), Nashville
Staedtisches Klinikum Braunschweig gGmbH ( Site 1217), Braunschweig
Universitaetsklinikum Magdeburg A.o.R. ( Site 1211), Magdeburg
Srinagarind Hospital ( Site 0604), Khon Kaen
Keski-Suomen keskussairaala ( Site 1017), Jyväskylä
Hospital Virgen de la Macarena ( Site 1904), Seville
Kyungpook National University Chilgok Hospital ( Site 0404), Daegu
Konya Necmettin Erbakan University Medical Faculty ( Site 2104), Konya
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 2607), Guadalajara
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0253), Cincinnati
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1503), Meldola
Institut Jean Godinot-Clinical Research Unit ( Site 1118), Reims
Centre D Oncologie de Gentilly ( Site 1107), Nancy
Chonnam National University Hwasun Hospital ( Site 0406), Jeollanam-do
Centre Bourgogne ( Site 1119), Lille
St. Vincent Frontier Cancer Center-Research ( Site 0213), Billings
The University of Chicago ( Site 0264), Chicago
Springfield Clinic [Springfield, IL] ( Site 0240), Springfield
Cotton-O'Neil Cancer Center ( Site 0228), Topeka
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1114), Strasbourg
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 1102), Pierre-Bénite
Centre Leon-Berard ( Site 1110), Lyon
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1509), Bari
Yitzhak Shamir Medical Center. ( Site 1405), Ẕerifin
National Cheng Kung University Hospital ( Site 0503), Tainan City
Boca Raton Clinical Research QTO ( Site 2611), Querétaro
Universitaetsklinikum Freiburg ( Site 1200), Freiburg im Breisgau
University of Colorado, Anschutz Cancer Pavilion ( Site 0236), Aurora
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1508), Napoli
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210), Munich
Klinikum Rechts der Isar ( Site 1206), München
Kaohsiung Chang Gung Memorial Hospital ( Site 0504), Kaohsiung City
Comprehensive Cancer Centers of Nevada ( Site 0269), Las Vegas
UCLA Hematology/Oncology - Santa Monica ( Site 0241), Los Angeles
Klinikum Nuernberg Nord ( Site 1213), Nuremberg
City of Hope Medical Center ( Site 0217), Duarte
Hopital Foch ( Site 1105), Suresnes
Hopital Henri Mondor ( Site 1116), Créteil
Azienda Ospedaliera Cannizzaro ( Site 1501), Catania
Fred Hutchinson Cancer Center ( Site 0258), Seattle
Alaska Clinical Research Center ( Site 0274), Anchorage
Providence Alaska Medical Center ( Site 0276), Anchorage
Peking University First Hospital ( Site 0800), Beijing
Beijing Cancer Hospital ( Site 0802), Beijing
SBIH City clinical hospital named after D.D. Pletniov ( Site 1813), Moscow
Administradora Country SA - Clinica del Country ( Site 2507), Bogotá
Instituto Nacional de Cancerologia E.S.E ( Site 2506), Bogotá
Russian Scientific Center of Roentgenoradiology ( Site 1800), Moscow
Harbin Medical University Cancer Hospital ( Site 0822), Harbin
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2509), Valledupar
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0807), Shanghai
Nanjing Drum Tower Hospital ( Site 0811), Nanjing
Tianjin Medical University Cancer Institute & Hospital ( Site 0804), Tianjin
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0808), Hangzhou
The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 0830), Hangzhou
Zhejiang Provincial People's Hospital ( Site 0809), Hangzhou
Ningbo First Hospital-Urology ( Site 0835), Ningbo
The First Affiliated Hospital of Wenzhou Medical University ( Site 0834), Wenzhou
The First Affiliated Hospital of Nanchang University ( Site 0821), Nanchang
The First Affiliated Hospital of Xiamen University ( Site 0816), Xiamen
Chongqing Cancer Hospital ( Site 0815), Chongqing
Hunan Cancer Hospital ( Site 0817), Changsha
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0829), Wuhan
Hubei Cancer Hospital ( Site 0833), Wuhan
Henan Cancer Hospital ( Site 0818), Zhengzhou
Sun Yat-Sen University Cancer Center ( Site 0825), Guangzhou
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0837), Guangdong
Sun Yat Sen Memorial Hospital ( Site 0819), Guangzhou
Southern Medical University Nanfang Hospital ( Site 0838), Guangzhou
Volga District Medical Center Federal Medical and Biological Agency ( Site 1805), Nizhny Novgorod
Omsk Clinical Oncology Dispensary ( Site 1809), Omsk
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1810), Krasnoyarsk
The Second Affiliated Hosp of Xi'an Jiaotong Univ College of Medicine ( Site 0831), Xi'an
The first affiliated Hospital of Xi an Jiaotong University ( Site 0812), Xi’an
Hemato Oncologos ( Site 2503), Santiago de Cali
IC La Serena Research ( Site 2406), La Serena
Oncocentro ( Site 2400), Viña del Mar
Rambam Health Care Campus-Oncology Division ( Site 1400), Haifa
Clinica Universidad Catolica del Maule ( Site 2407), Talca
Meir Medical Center ( Site 1401), Kfar Saba
Centro Investigación del Cáncer James Lind ( Site 2401), Temuco
Rabin Medical Center ( Site 1402), Petah Tikva
Sourasky Medical Center ( Site 1403), Tel Aviv
Clinica Alemana ( Site 2408), Santiago
Pontificia Universidad Catolica de Chile ( Site 2402), Santiago
Bradfordhill ( Site 2403), Santiago
Hadassah Ein Kerem Medical Center ( Site 1404), Jerusalem
Hartford HealthCare Medical Group ( Site 0212), Manchester
Smilow Cancer Center at Yale-New Haven ( Site 0250), New Haven
Winship Cancer Institute of Emory University ( Site 0209), Atlanta
Oncocentro Ceara ( Site 2309), Fortaleza
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 2306), Curitiba
Hospital Sao Vicente de Paulo ( Site 2303), Passo Fundo
Hospital de Clinicas de Porto Alegre ( Site 2304), Porto Alegre
Clinica de Oncologia Reichow ( Site 2308), Blumenau
Fundacao Dr Amaral Carvalho ( Site 2302), Jaú
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2305), São Paulo
The Ottawa Hospital ( Site 0100), Ottawa
Niagara Health System - St. Catharines ( Site 0107), St. Catharines
CISSS de la Monteregie-Centre ( Site 0105), Greenfield Park
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0109), Montreal
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0106), Montreal
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0101), Québec
Clinica de la Costa S.A.S. ( Site 2504), Barranquilla
HYKS ( Site 1020), Helsinki
Universitaetsklinikum der Technischen Universitaet Dresden ( Site 1204), Dresden
St Vincents University Hospital ( Site 1300), Dublin
Cork University Hospital ( Site 1304), Cork
Tallaght University Hospital ( Site 1301), Dublin
Beaumont Hospital ( Site 1302), Dublin
University Hospital Limerick ( Site 1305), Limerick
University Hospital Waterford ( Site 1303), Waterford
Fondazione Policlinico Universitario A. Gemelli ( Site 1512), Rome
Azienda Ospedaliera Santa Maria ( Site 1502), Terni
Toho University Sakura Medical Center ( Site 0732), Sakura
Ehime University Hospital ( Site 0745), Tōon
Sapporo Medical University Hospital ( Site 0730), Sapporo
Kitasato University Hospital ( Site 0734), Sagamihara
Yokohama City University Medical Center ( Site 0735), Yokohama
Nara Medical University Hospital ( Site 0744), Kashihara
Kindai University Hospital ( Site 0743), Sayama
The University of Osaka Hospital ( Site 0742), Suita
Saitama Medical University International Medical Center ( Site 0737), Hidaka
Dokkyo Medical University Saitama Medical Center ( Site 0736), Koshigaya
Hamamatsu University Hospital ( Site 0748), Hamamatsu
Yamaguchi University Hospital ( Site 0746), Ube
Chiba Cancer Center ( Site 0733), Chiba
Harasanshin Hospital ( Site 0747), Fukuoka
Nagano Municipal Hospital ( Site 0731), Nagano
Osaka Metropolitan University Hospital ( Site 0741), Osaka
Toranomon Hospital ( Site 0740), Tokyo
Nippon Medical School Hospital ( Site 0738), Tokyo
Tokyo Women's Medical University ( Site 0739), Tokyo
Grupo Medico Camino SC ( Site 2613), Mexico City
Centro Oncologico Internacional. SEDNA ( Site 2609), Mexico City
Radboud University Medical Center ( Site 1606), Nijmegen
Antoni van Leeuwenhoek Ziekenhuis ( Site 1603), Amsterdam
Vrije Universiteit Medisch Centrum ( Site 1601), Amsterdam
Isala Klinieken, Locatie Sophia ( Site 1604), Zwolle
Franciscus Gasthuis en Vlietland ( Site 1605), Schiedam
Meander Medisch Centrum ( Site 1602), Amersfoort
St. Antonius Ziekenhuis ( Site 1600), Utrecht
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 2700), Arequipa
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 1710), Poznan
Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1720), Bydgoszcz
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1716), Bydgoszcz
MICS Centrum Medyczne Torun ( Site 1718), Torun
Szpital Uniwersytecki w Krakowie ( Site 1707), Krakow
Radomskie Centrum Onkologii ( Site 1701), Radom
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1700), Przemyśl
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1717), Bytom
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1709), Koszalin
Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1721), Szczecin
Seoul National University Hospital ( Site 0405), Seoul
Severance Hospital Yonsei University Health System ( Site 0402), Seoul
Asan Medical Center ( Site 0403), Seoul
Instituto Catalan de Oncologia - ICO ( Site 1901), L'Hospitalet de Llobregat
Ankara Bilkent Sehir Hastanesi ( Site 2103), Ankara
Acibadem Adana Hastanesi ( Site 2106), Adana
Ankara Universitesi Tip Fakultesi. ( Site 2101), Ankara
Hacettepe Universitesi Tıp Fakultesi ( Site 2105), Ankara
Aberdeen Royal Infirmary ( Site 1315), Aberdeen
Royal Cornwall Hospitals NHS Trust ( Site 1317), Truro
University College London Hospitals NHS Foundation Trust ( Site 1320), London
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1318), London
Velindre Cancer Centre Hospital ( Site 1322), Cardiff
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INDUSTRY