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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
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
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (203)
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
Hospital Samaritano de Sao Paulo
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