Spots Global Cancer Trial Database for A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
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Trial Identification
Brief Title: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
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)
Study ID: NCT05884398
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Centers Of Alabama, Homewood, Alabama, United States
Arizona Urology Specialists, Tucson, Arizona, United States
Arkansas Urology, Little Rock, Arkansas, 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
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, 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 Bergonié, Bordeaux, , France
Centre Leon Berard, Lyon, , France
Hopital Cochin, Paris, , France
Chu Rennes Hopital Pontchaillou, Rennes, , France
Gustave Roussy, Villejuif Cedex, , France
Universitaetsklinikum der RWTH Aachen, Aachen, , Germany
Klinikum Augsburg, Augsburg, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden, , Germany
Universitaetsklinikum Koelnt, Koeln, , Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck, Lubeck, , Germany
Klinikum rechts der Isar - der Technischen Universität München, Muenchen, , Germany
Studienpraxis Urologie Nurtingen, Nuertingen, , Germany
Universitatsklinikum Wurzburg, Würzburg, , Germany
SCIENTIA Investigacion Clinica SC, Chihuahua, , Mexico
Consultorio de Especialidad en Urologia Privado, Durango, , Mexico
Medical Care & Research SA de CV, Merida, , Mexico
Cuidados Oncologicos, Queretaro, , Mexico
Centrum Onkologii im. Prof. F. Lukaszczyka, Bydgoszcz, , Poland
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Koszalin, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., Warszawa, , Poland
Specjalistyczna przychodnia lekarska POLIMED, Wroclaw, , Poland
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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