420
Participants
Start Date
August 31, 2023
Primary Completion Date
August 31, 2026
Study Completion Date
August 31, 2026
Apalutamide
Apalutamide will be administered orally from Day 1 of Cycle 1 till 6 months in initial treatment phase and then in main treatment phase from Day 1 of Cycle 7 up to at least 18 months.
Androgen-deprivation Therapy (ADT)
The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Macquarie University Hospital, Macquarie University
Peter MacCallum Cancer Centre, Melbourne
Mater Misericordiae Hospital, South Brisbane
Columbia University Medical Center, New York
Memorial Sloan Kettering Cancer Center, New York
MSKCC Westchester, Harrison
MSKCC Nassau Regional Cancer Center, Uniondale
MSKCC Commack, Commack
Associated Medical Professionals, Syracuse
University of Pittsburgh Medical Center, Pittsburgh
VA Pittsburgh, Pittsburgh
Centers for Advanced Urology LLC d b a MidLantic Urology, Bala-Cynwyd
Maryland Oncology Hematology P A, Silver Spring
Chesapeake Urology Research Associates, Towson
Urology Of Virginia, Pllc, Virginia Beach
Virginia Oncology Associates, Norfolk
Universitatsklinikum Schleswig Holstein Campus Lubeck, Lübeck
SCIENTIA Investigacion Clinica SC, Chihuahua City
Advanced Urology Institute, Daytona Beach
Institut Bergonie, Bordeaux
Consultorio de Especialidad en Urologia Privado, Durango
Chu Rennes Hopital Pontchaillou, Rennes
Urology Centers Of Alabama, Homewood
Urology Associates, Nashville
The Conrad Pearson Clinic, Germantown
Central Ohio Urology Group, Gahanna
Helios Clinical Research, LLC, Middleburg Heights
TriState Urologic Services PSC Inc. DBA The Urology Group, Cincinnati
Urology of Indiana, Greenwood
First Urology, PSC, Jeffersonville
Michigan Institute of Urology, Troy
Universitaetsklinikum Koelnt, Cologne
Universitaetsklinikum der RWTH Aachen, Aachen
Associated Urological Specialists LLC, Chicago Ridge
Advanced Urology Associates, Joliet
Centre Leon Berard, Lyon
Arkansas Urology, Little Rock
Studienpraxis Urologie Nurtingen, Nürtingen
Hopital Cochin, Paris
Parkland Health and Hospital System, Dallas
Texas Oncology P A, Dallas
UT Southwestern Medical Center, Dallas
Cuidados Oncologicos, Querétaro
Texas Oncology P A, Wichita Falls
Texas Oncology P A, Houston
Houston Metro Urology, Houston
Texas Oncology San Antonio Northeast, San Antonio
Texas Oncology P A, Austin
Colorado Clinical Research, Lakewood
Klinikum rechts der Isar - der Technischen Universität München, München
University of Utah Huntsman Cancer Institute, Salt Lake City
Arizona Urology Specialists, Tucson
Sansum Clinic Pharm, Santa Barbara
Urology Associates of Central California, Fresno
VA Medical Center, San Francisco
Gustave Roussy, Villejuif
Medical Care & Research SA de CV, Mérida
Universitatsklinikum Wurzburg, Würzburg
Northwest Cancer Specialists PC, Tigard
Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke
Peking University First Hospital, Beijing
Shengjing Hospital Of China Medical University, Shenyang
The First Hospital of Jilin University, Changchun
Shandong Provincial Hospital, Jinan
Ningbo First Hospital, Ningbo
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology, Wuhan
The First Affiliated Hospital Sun Yat sen University, Guangzhou
Nanfang Hospital of Southern Medical Hospital, Guangzhou
West China School of Medicine/West China Hospital, Sichuan University, Chengdu
The First Affiliated Hospital of Xian Jiaotong University, Xi'an
MSKCC Basking Ridge, Basking Ridge
MSKCC Monmouth, Middletown
MSKCC Bergen, Montvale
Fundacao Pio XII, Barretos
Hospital das Clínicas - Universidade Federal de Minas Gerais, Belo Horizonte
Liga Norte Riograndense Contra O Cancer, Natal
Ministerio da Saude Instituto Nacional do Cancer, Rio de Janeiro
Instituto D Or de Pesquisa e Ensino, Salvador
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo André
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo, São Paulo
Southern Alberta Institute of Urology / Prostate Cancer Centre, Calgary
Nova Scotia Health Authority, Halifax
Sunnybrook Health Sciences Center, Toronto
Princess Margaret Hospital, Toronto
CHU de Quebec Universite Laval Hopital de l Enfant Jesus, Québec
Klinikum Augsburg, Augsburg
Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden
Centrum Onkologii im Prof F Lukaszczyka, Bydgoszcz
Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie, Koszalin
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warsaw
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O, Warsaw
Polimed Specjalistyczna Przychodnia Lekarska Wieslaw Grazyna Tupikowski Bednarek Tupikowska S C, Wroclaw
Janssen Research & Development, LLC
INDUSTRY