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ACTIVE NOT RECRUITING
NCT03767244
PHASE3

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2517

Start Date

2019-06-11

Completion Date

2028-10-13

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Apalutamide

Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.

DRUG

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 \[ng/dL\]).

DRUG

Placebo

Participants will receive matching placebo oral tablets daily.

Locations (202)

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California Irvine Medical Center Chao Family Comprehensive Cancer Center

Orange, California, United States

UC Davis Medical Center

Sacramento, California, United States

AdventHealth Medical Group Urology of Denver

Denver, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Stamford Hospital

Stamford, Connecticut, United States

Urology Specialists LLC

Hialeah, Florida, United States

Mayo Clinic - Division Of Hematology/oncology

Jacksonville, Florida, United States

Miami Cancer Institute at Baptist Health / Baptist Health Medical Group

Miami, Florida, United States

Advent Health

Orlando, Florida, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Ochsner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States

Michigan Institute of Urology, PC

Troy, Michigan, United States

Saint Louis University

St Louis, Missouri, United States

Urology Cancer Center, PC

Omaha, Nebraska, United States

Albany Medical College

Albany, New York, United States

Great Lakes Physician PC d/b/a Western New York Urology Associates

Cheektowaga, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University School of Medicine

Durham, North Carolina, United States

Medication Management LLC

Greensboro, North Carolina, United States

Carolina Urology Partners, PLLC

Huntersville, North Carolina, United States

Cleveland VA Medical Center

Cleveland, Ohio, United States

Oklahoma City VAMC

Oklahoma City, Oklahoma, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Omega Medical Research

Warwick, Rhode Island, United States

Ralph H. Johnson Veterans Affairs Medical Center

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Greenville Health

Greenville, South Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

VA North Texas Health Care System

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Virginia Urology

Richmond, Virginia, United States

Urology of Virginia, PLCC

Virginia Beach, Virginia, United States

CAMC Memorial Hospital, Charleston Area Medical Center Physicians

Charleston, West Virginia, United States

Hospital Aleman

Caba, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de, Argentina

Centro Urologico Profesor Bengio

Córdoba, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Uroclinica

Mendoza, Argentina

Clinica Mayo de UMCB

San Miguel de Tucumán, Argentina

Eastern Health - Box Hill Hospital

Box Hill, Australia

St Vincent s Hospital Sydney

Darlinghurst, Australia

Austin Health

Heidelberg, Australia

Australian Urology Associates Pty Ltd

Malvern, Australia

Royal Melbourne Hospital

Parkville, Australia

Northern Cancer Institute

St Leonards, Australia

Sydney Adventist Hospital

Wahroonga, Australia

Westmead Hospital

Westmead, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

Goiânia, Brazil

Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

Ijuí, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Universidade do Estado do Rio de Janeiro - UERJ

Rio de Janeiro, Brazil

Associacao Umane

São Paulo, Brazil

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

Instituto Do Cancer Brasil

Três Lagoas, Brazil

Prostate Cancer Centre

Calgary, Alberta, Canada

Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

London Health Sciences Center

London, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

CHUM - Centre hospitalier universitaire de Montreal

Montreal, Quebec, Canada

CHU de Quebec Universite Laval Hopital de l Enfant Jesus

Québec, Quebec, Canada

Fakultni nemocnice Hradec Kralove

Hradec Králove, Czechia

Krajská nemocnice Liberec

Liberec, Czechia

Uromedical Center s.r.o.

Olomouc, Czechia

Fakultni nemocnice Plzen, Urologicka klinika

Pilsen, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Thomayerova nemocnice

Prague, Czechia

CHU d'Angers

Angers, France

CHRU Besancon Hopital Jean Minjoz

Besançon, France

Hopital Pellegrin CHU Bordeaux

Bordeaux, France

APHP - Hopital Henri Mondor

Créteil, France

Hopital Edouard Herriot - CHU Lyon

Lyon, France

CHU de Nantes hotel Dieu

Nantes, France

Institut Mutualiste Montsouris

Paris, France

Clinique de la Croix du Sud

Quint-Fonsegrives, France

Chu Rennes Hopital Pontchaillou

Rennes, France

CHU de Toulouse - Hôpital Rangueil

Toulouse, France

CHRU Tours Hopital Bretonneau

Tours, France

Universitaetsklinikum der RWTH Aachen

Aachen, Germany

Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

Braunschweig, Germany

Universitaetsklinikum Koelnt

Cologne, Germany

Praxis Dr. med. Ralf Eckert

Eisleben Lutherstadt, Germany

Universitatsklinikum Essen

Essen, Germany

Universitatsklinikum Frankfurt

Frankfurt am Main, Germany

Prostata zentrum Nordwest

Gronau, Germany

Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

Hamburg, Germany

Universitätsklinikum des Saarlandes

Homburg/Saar, Germany

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, Germany

Klinikum St. Elisabeth Straubing GmbH

Straubing, Germany

Kliniken Nordoberpfalz, Klinik für Urologie

Weiden/Opf, Germany

Praxisgemeinschaft f. Onkologie u. Urologie - Germany

Wilhelmshaven, Germany

Asaf Harofe Medical Center

Beer Yaakov, Israel

Rambam Health Care Campus

Haifa, Israel

Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Policlinico Abano Terme

Abano Terme, Italy

Generale Regionale F. Miulli

Acquaviva delle Fonti, Italy

Ospedale di Bassano del Grappa

Bassano del Grappa, Italy

ASST Spedali Civili Brescia

Brescia, Italy

ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti

Chieti, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia

Modena, Italy

Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

Novara, Italy

Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Italy

Universita Campus Bio-Medico di Roma

Roma, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Azienda Ospedaliera Sant Andrea

Roma, Italy

Ospedale Molinette, AO Città della Salute e della Scienza di

Torino, Italy

UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento

Verona, Italy

Akita University Hospital

Akita, Japan

Chiba University Hospital

Chiba, Japan

Chiba Cancer Center

Chūōku, Japan

Hakodate Goryoukaku Hospital

Hakodate, Japan

Hirosaki University Hospital

Hirosaki, Japan

Kanazawa University Hospital

Kanazawa, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Japan

Kurume University Hospital

Kurume, Japan

Kyoto University Hospital

Kyoto, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

Kitasato University Hospital

Minamiku, Japan

University of Miyazaki Hospital

Miyazaki, Japan

Nagano Municipal Hospital

Nagano, Japan

Osaka International Cancer Institute

Osaka, Japan

Kindai University Hospital

Sakai, Japan

Toho University Sakura Medical Center

Sakura, Japan

Hokkaido University Hospital

Sapporo, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

Nippon Medical School Hospital

Tokyo, Japan

Juntendo University Hospital

Tokyo, Japan

Yamaguchi University Hospital

Ube, Japan

Yokohama City University Medical Center

Yokohama, Japan

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Catharinaziekenhuis

Eindhoven, Netherlands

St. Antonius Ziekenhuis (St. Antonius Hospital)

Nieuwegein, Netherlands

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Samodzielny Publiczny Wielospecjalistyczny Zaklad Opieki Zdrowotnej Mswia W Bydgoszczy

Bydgoszcz, Poland

Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

Bydgoszcz, Poland

Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

Koszalin, Poland

Pratia MCM Krakow

Krakow, Poland

City Clinic Sp. z o.o.

Warsaw, Poland

Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia

Wroclaw, Poland

Altai Regional Oncology Dispensary

Barnaul, Russia

Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

Chelyabinsk, Russia

Moscow City Clinical Hospital # 62

Moscow, Russia

Hertzen Oncology Research Institute

Moscow, Russia

Clinical Oncology Dispensary

Omsk, Russia

Medical-sanitary unit 'Neftyanik'

Tyumen, Russia

Vologda Regional Oncological Dispensary

Vologda, Russia

Chonnam National University Hospital

Gwangju, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Hosp Univ A Coruna

A Coruña, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Puerta Del Mar

Cadiz, Spain

Hosp. Gral. Univ. de Castellon

Castellon, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Fund. Hosp. de Manacor

Manacor, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Inst. Valenciano de Oncologia

Valencia, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Tungs' Taichung MetroHarbor Hospital

Taichung, Taiwan

Chi Mei Medical Center Yong Kang

Tainan, Taiwan

National Taiwan University Hospital.

Taipei, Taiwan

Southmead Hospital

Bristol, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Ninewells Hospital

Dundee, United Kingdom

The Royal Marsden NHS Trust

London, United Kingdom

University College London

London, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

Preston, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

Mid Yorkshire NHS Trust

Wakefield, United Kingdom

New Cross Hospital

Wolverhampton, United Kingdom