2,517
Participants
Start Date
June 11, 2019
Primary Completion Date
February 10, 2026
Study Completion Date
July 19, 2029
Apalutamide
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Androgen Deprivation Therapy (ADT)
Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter \[ng/dL\]).
Placebo
Participants will receive matching placebo oral tablets daily.
Tungs' Taichung MetroHarbor Hospital, Taichung
Chi Mei Medical Center Yong Kang, Tainan City
Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City
Hospital Aleman, Caba
St Vincent s Hospital Sydney, Darlinghurst
Northern Cancer Institute, St Leonards
Sydney Adventist Hospital, Wahroonga
Westmead Hospital, Westmead
Royal Melbourne Hospital, Parkville
Austin Health, Heidelberg
Australian Urology Associates Pty Ltd, Malvern
Clinica Mayo de UMCB, San Miguel de Tucumán
Princess Alexandra Hospital, Woolloongabba
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Córdoba
Uroclinica, Mendoza
Hosp Univ Vall D Hebron, Barcelona
National Taiwan University Hospital., Taipei
Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano
Memorial Sloan-Kettering Cancer Center, New York
Weill Cornell Medical College, New York
Ospedale Molinette, AO Città della Salute e della Scienza di, Torino
Hosp. Puerta Del Mar, Cadiz
Hosp. de Jerez de La Frontera, Jerez de la Frontera
Hosp. Gral. Univ. de Castellon, Castellon
Albany Medical College, Albany
SUNY Upstate Medical University, Syracuse
Seoul National University Bundang Hospital, Gyeonggi-do
Great Lakes Physician PC d/b/a Western New York Urology Associates, Cheektowaga
Hosp Univ A Coruna, A Coruña
MidLantic Urology, Bala-Cynwyd
San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico, Milan
Ospedale San Raffaele, Milan
Istituto Europeo di Oncologia, Milan
Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie, Hamburg
Virginia Urology, Richmond
Urology of Virginia, PLCC, Virginia Beach
Universitatsklinikum Schleswig Holstein Campus Lubeck, Lübeck
CHRU Besancon Hopital Jean Minjoz, Besançon
ASST Spedali Civili Brescia, Brescia
CAMC Memorial Hospital, Charleston Area Medical Center Physicians, Charleston
Praxisgemeinschaft f. Onkologie u. Urologie - Germany, Wilhelmshaven
Medication Management LLC, Greensboro
University of North Carolina, Chapel Hill
Duke University School of Medicine, Durham
Hosp. Univ. Ramon Y Cajal, Madrid
Hosp. Univ. 12 de Octubre, Madrid
Hosp. Univ. La Paz, Madrid
Carolina Urology Partners, PLLC, Huntersville
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara, Novara
Hosp Virgen de La Victoria, Málaga
Medical University of South Carolina, Charleston
Ralph H. Johnson Veterans Affairs Medical Center, Charleston
Carolina Urologic Research Center, Myrtle Beach
Greenville Health, Greenville
CHU de Toulouse - Hôpital Rangueil, Toulouse
Rambam Health Care Campus, Haifa
Clinique de la Croix du Sud, Quint-Fonsegrives
Mayo Clinic - Division Of Hematology/oncology, Jacksonville
Florida Hospital, Orlando
Urology Specialists LLC, Hialeah
Hopital Pellegrin CHU Bordeaux, Bordeaux
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group, Miami
Policlinico Abano Terme, Abano Terme
Chu Rennes Hopital Pontchaillou, Rennes
Ospedale di Bassano del Grappa, Bassano del Grappa
CHRU Tours Hopital Bretonneau, Tours
UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento, Verona
Vanderbilt University Medical Center, Nashville
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer, Braunschweig
Hosp. Univ. Marques de Valdecilla, Santander
China Medical University Hospital, Taichung
Taichung Veterans General Hospital, Taichung
Hosp. Virgen Del Rocio, Seville
Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia, Modena
CHU de Nantes hotel Dieu, Nantes
Cleveland VA Medical Center, Cleveland
Universitatsklinikum Essen, Essen
Inst. Valenciano de Oncologia, Valencia
Hosp. Clinico Univ. de Valencia, Valencia
Michigan Institute of Urology, PC, Troy
Prostata zentrum Nordwest, Gronau
Rabin Medical Center, Petah Tikva
CHU d'Angers, Angers
Azienda Ospedaliero Universitaria Careggi, Florence
Universitaetsklinikum Koelnt, Cologne
Universitaetsklinikum der RWTH Aachen, Aachen
The Chaim Sheba Medical Center, Ramat Gan
Universitatsklinikum Frankfurt, Frankfurt am Main
University of Chicago, Chicago
Asaf Harofe Medical Center, Beer Yaakov
Chonnam National University Hospital, Gwangju
Saint Louis University, St Louis
Tel Aviv Sourasky Medical Center, Tel Aviv
ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti, Chieti
Universitätsklinikum des Saarlandes, Homburg/Saar
Urology Cancer Center, PC, Omaha
Hopital Edouard Herriot - CHU Lyon, Lyon
Generale Regionale F. Miulli, Acquaviva delle Fonti
Ochsner LSU Health Shreveport - Regional Urology, Shreveport
Oklahoma City VAMC, Oklahoma City
Institut Mutualiste Montsouris, Paris
VA North Texas Health Care System, Dallas
MD Anderson Cancer Center, Houston
Uromedical Center s.r.o., Olomouc
AdventHealth Medical Group Urology of Denver, Denver
Colorado Clinical Research, Lakewood
University of Southern California, Los Angeles
Cedars Sinai Medical Center, Los Angeles
University of California Los Angeles, Los Angeles
UC San Diego Moores Cancer Center, La Jolla
Kliniken Nordoberpfalz, Klinik für Urologie, Weiden/Opf
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center, Orange
APHP - Hopital Henri Mondor, Créteil
Klinikum St. Elisabeth Straubing GmbH, Straubing
UC Davis Medical Center, Sacramento
Moscow City Clinical Hospital # 62, Moscow
Hertzen Oncology Research Institute, Moscow
Vologda Regional Oncological Dispensary, Vologda
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine, Chelyabinsk
Medical-sanitary unit 'Neftyanik', Tyumen
Clinical Oncology Dispensary, Omsk
Altai Regional Oncology Dispensary, Barnaul
Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC), Kfar Saba
Stamford Hospital, Stamford
Emory University Winship Cancer Institute, Atlanta
Dana Farber Cancer Institute, Boston
Beth Isreal Deaconess Medical Center, Boston
Omega Medical Research, Warwick
Hospital Italiano de Buenos Aires, Ciudad Autonoma de
Centro Urologico Profesor Bengio, Córdoba
Epworth Eastern Hospital, Box Hill
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge, Goiânia
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda, Ijuí
Liga Norte Riograndense Contra O Cancer, Natal
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro
Associacao Umane, São Paulo
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo, São Paulo
Instituto Do Cancer Brasil, Três Lagoas
Prostate Cancer Centre, Calgary
Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver
Nova Scotia Health Authority, Halifax
London Health Sciences Center, London
Sunnybrook Health Sciences Center, Toronto
Princess Margaret Cancer Centre University Health Network, Toronto
CHUM - Centre hospitalier universitaire de Montreal, Montreal
CHU de Quebec Universite Laval Hopital de l Enfant Jesus, Québec
Fakultni nemocnice Hradec Kralove, Hradec Králove
Krajská nemocnice Liberec, Liberec
Fakultni nemocnice Plzen, Urologicka klinika, Pilsen
Vseobecna fakultni nemocnice v Praze, Prague
Thomayerova nemocnice, Prague
Praxis Dr. med. Ralf Eckert, Eisleben Lutherstadt
Universita Campus Bio-Medico di Roma, Roma
Istituto Nazionale Tumori Regina Elena, Roma
Azienda Ospedaliera Sant Andrea, Roma
Akita University Hospital, Akita
Chiba University Hospital, Chiba
Chiba Cancer Center, Chūōku
Hakodate Goryoukaku Hospital, Hakodate
Hirosaki University Hospital, Hirosaki
Kanazawa University Hospital, Kanazawa
Kobe City Medical Center General Hospital, Kobe
Dokkyo Medical University Saitama Medical Center, Koshigaya
Kurume University Hospital, Kurume
Kyoto University Hospital, Kyoto
National Hospital Organization Shikoku Cancer Center, Matsuyama
Kitasato University Hospital, Minamiku
University of Miyazaki Hospital, Miyazaki
Nagano Municipal Hospital, Nagano
Osaka International Cancer Institute, Osaka
Kindai University Hospital, Osaka Sayama Shi
Toho University Sakura Medical Center, Sakura
Hokkaido University Hospital, Sapporo
Iwate Medical University Hospital, Shiwa-gun
Nippon Medical School Hospital, Tokyo
Juntendo University Hospital, Tokyo
Yamaguchi University Hospital, Ube
Yokohama City University Medical Center, Yokohama
Antoni van Leeuwenhoek, Amsterdam
Catharinaziekenhuis, Eindhoven
St. Antonius Ziekenhuis (St. Antonius Hospital), Nieuwegein
Canisius-Wilhelmina Ziekenhuis, Nijmegen
Samodzielny Publiczny Wielospecjalistyczny Zaklad Opieki Zdrowotnej Mswia W Bydgoszczy, Bydgoszcz
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza, Bydgoszcz
Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie, Koszalin
Pratia MCM Krakow, Krakow
City Clinic Sp. z o.o., Warsaw
Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia, Wroclaw
Severance Hospital Yonsei University Health System, Seoul
Asan Medical Center, Seoul
The Catholic University of Korea Seoul St Marys Hospital, Seoul
Fund. Hosp. de Manacor, Manacor
Southmead Hospital, Bristol
University Hospital of Wales, Cardiff
Ninewells Hospital, Dundee
The Royal Marsden NHS Trust, London
University College London, London
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital, Preston
Royal Marsden Hospital, Sutton
Mid Yorkshire NHS Trust, Wakefield
New Cross Hospital, Wolverhampton
Janssen Research & Development, LLC
INDUSTRY