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A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
Official title: A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2023-08-31
Completion Date
2028-10-12
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
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.
Locations (93)
Urology Centers Of Alabama
Homewood, Alabama, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Arizona Urology Specialists
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Urology Associates of Central California
Fresno, California, United States
VA Medical Center
San Francisco, California, United States
Sansum Clinic Pharm
Santa Barbara, California, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Associated Urological Specialists LLC
Chicago Ridge, Illinois, United States
Advanced Urology Associates
Joliet, Illinois, United States
Urology of Indiana
Greenwood, Indiana, United States
First Urology, PSC
Jeffersonville, Indiana, United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States
Michigan Institute of Urology
Troy, Michigan, United States
MSKCC Basking Ridge
Basking Ridge, New Jersey, United States
MSKCC Monmouth
Middletown, New Jersey, United States
MSKCC Bergen
Montvale, New Jersey, United States
MSKCC Commack
Commack, New York, United States
MSKCC Westchester
Harrison, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Associated Medical Professionals
Syracuse, New York, United States
MSKCC Nassau Regional Cancer Center
Uniondale, New York, United States
TriState Urologic Services PSC Inc. DBA The Urology Group
Cincinnati, Ohio, United States
Central Ohio Urology Group
Gahanna, Ohio, United States
Helios Clinical Research, LLC
Middleburg Heights, Ohio, United States
Northwest Cancer Specialists PC
Tigard, Oregon, United States
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
VA Pittsburgh
Pittsburgh, Pennsylvania, United States
The Conrad Pearson Clinic
Germantown, Tennessee, United States
Urology Associates
Nashville, Tennessee, United States
Texas Oncology P A
Austin, Texas, United States
Parkland Health and Hospital System
Dallas, Texas, United States
Texas Oncology P A
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Oncology P A
Houston, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Texas Oncology San Antonio Northeast
San Antonio, Texas, United States
Texas Oncology P A
Wichita Falls, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
Urology Of Virginia, Pllc
Virginia Beach, Virginia, United States
Macquarie University Hospital
Macquarie University, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Mater Misericordiae Hospital
South Brisbane, Australia
Fundacao Pio XII
Barretos, Brazil
Hospital das Clínicas - Universidade Federal de Minas Gerais
Belo Horizonte, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, Brazil
Instituto D Or de Pesquisa e Ensino
Salvador, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, Brazil
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary, Alberta, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHU de Quebec Universite Laval Hopital de l Enfant Jesus
Québec, Quebec, Canada
Peking University First Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
West China School of Medicine/West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, China
Shandong Provincial Hospital
Jinan, China
Ningbo First Hospital
Ningbo, China
Shengjing Hospital Of China Medical University
Shenyang, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Institut Bergonie
Bordeaux, France
Centre Leon Berard
Lyon, France
Hopital Cochin
Paris, France
Chu Rennes Hopital Pontchaillou
Rennes, France
Gustave Roussy
Villejuif, France
Universitaetsklinikum der RWTH Aachen
Aachen, Germany
Klinikum Augsburg
Augsburg, Germany
Universitaetsklinikum Koelnt
Cologne, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck, Germany
Klinikum rechts der Isar - der Technischen Universität München
München, Germany
Studienpraxis Urologie Nurtingen
Nürtingen, Germany
Universitatsklinikum Wurzburg
Würzburg, Germany
SCIENTIA Investigacion Clinica SC
Chihuahua City, Mexico
Consultorio de Especialidad en Urologia Privado
Durango, Mexico
Medical Care & Research SA de CV
Mérida, Mexico
Cuidados Oncologicos
Querétaro, Mexico
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, Poland
Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
Koszalin, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
Warsaw, Poland
Polimed Specjalistyczna Przychodnia Lekarska Wieslaw Grazyna Tupikowski Bednarek Tupikowska S C
Wroclaw, Poland