A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
NCT ID: NCT05884398
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
420 participants
INTERVENTIONAL
2023-08-31
2028-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Intermittent ADT Group)
Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and treated with apalutamide with intermittent ADT per protocol or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) and followed up for up to a maximum of 2 years after the main treatment phase, or until death, withdrawal of consent, loss to follow-up, early termination of the study by the sponsor for any reason, whichever occurs first.
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.
Arm B (Continuous ADT Group)
Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and continue to receive apalutamide plus ADT or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) and followed up for up to a maximum of 2 years after the main treatment phase, or until death, withdrawal of consent, loss to follow-up, early termination of the study by the sponsor for any reason, whichever occurs first.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* For participants not undergoing Gender-affirming care: Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or bone scan) and/or next-generation imaging \[NGI\] demonstrating greater than or equal (\>=) 2 distinct extraprostatic sites of metastasis
* For participants undergoing Gender-affirming care: No evidence of metastasis by either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also acceptable
* For participants not undergoing gender-affirming care: testosterone levels \> 50 (ng/dL) nanograms per deciliter at screening, except for those who may have received ADT prior to screening. Participants are allowed to have received up to 3 months of (ADT) androgen-deprivation therapy prior to enrollment
* For participants undergoing Gender-affirming care: There is no testosterone level requirement for inclusion
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
* A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
* Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
* Assigned male at birth, inclusive of all gender identities
Exclusion Criteria
* Pelvic lymph nodes as only site of metastasis
* Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
* Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
* Gastrointestinal disorder affecting absorption
* Participants who have undergone a bilateral orchiectomy with the exception of participants who completed this as part of their gender-affirming care or a result of a variation in physical sex development
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Urology Centers Of Alabama
Homewood, Alabama, 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
Countries
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Other Identifiers
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56021927PCR3020
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502686-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109327
Identifier Type: -
Identifier Source: org_study_id