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NCT05884398Active, not recruitingPhase 3

A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC

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)

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
420 (actual)
First submitted
23 May 2023
Start date
31 Aug 2023
Primary completion date
12 Oct 2026
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05884398
EU CT number
2022-502686-24-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 420
  • From 31 Aug 2023 to the primary completion date, 12 Oct 2026
  • 91 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
  • Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
  • Gastrointestinal disorder affecting absorption

Other

  • Pelvic lymph nodes as only site of metastasis
  • 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

Who the study is looking for

  • Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (91)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Macquarie University Hospital
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Macquarie UniversityAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Mater Misericordiae Hospital
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South BrisbaneAustraliaUnknown status
Fundacao Pio XII
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BarretosBrazilUnknown status
Hospital das Clínicas - Universidade Federal de Minas Gerais
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Belo HorizonteBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Ministerio da Saude Instituto Nacional do Cancer
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Rio de JaneiroBrazilUnknown status
IDOR - Regional Bahia
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SalvadorBrazilUnknown status
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
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Santo AndréBrazilUnknown status
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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São PauloBrazilUnknown status
Southern Alberta Institute of Urology / Prostate Cancer Centre
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CalgaryCanadaUnknown status
Nova Scotia Health Authority
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HalifaxCanadaUnknown status
CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus
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QuébecCanadaUnknown status
Princess Margaret Hospital
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TorontoCanadaUnknown status
Sunnybrook Health Sciences Center
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TorontoCanadaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
West China School of Medicine/West China Hospital, Sichuan University
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ChengduChinaUnknown status
Nanfang Hospital of Southern Medical Hospital
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Shandong Provincial Hospital
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JinanChinaUnknown status
Ningbo First Hospital
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NingboChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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WuhanChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
Universitaetsklinikum Aachen AöR
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AachenGermanyActive, not recruiting
Universitaetsklinikum Augsburg
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AugsburgGermanyActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
Technische Universität Dresden
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyActive, not recruiting
Studienpraxis Urologie
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NürtingenGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Institut Bergonie
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BordeauxFranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
SCIENTIA Investigacion Clinica SC
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Chihuahua CityMexicoUnknown status
Consultorio de Especialidad en Urologia Privado
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DurangoMexicoUnknown status
Medical Care & Research Sa de Cv
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MéridaMexicoUnknown status
Cuidados Oncologicos
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QuerétaroMexicoUnknown status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandActive, not recruiting
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
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KoszalinPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
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WarsawPolandActive, not recruiting
Polimed Specjalistyczna Przychodnia Lekarska
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WroclawPolandActive, not recruiting
Texas Oncology P A
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AustinUnited StatesUnknown status
Centers for Advanced Urology LLC d b a MidLantic Urology
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Bala-CynwydUnited StatesUnknown status
MSKCC Basking Ridge
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Basking RidgeUnited StatesUnknown status
Associated Urological Specialists LLC
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Chicago RidgeUnited StatesUnknown status
TriState Urologic Services PSC Inc. DBA The Urology Group
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CincinnatiUnited StatesUnknown status
MSKCC @ Commack
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CommackUnited StatesUnknown status
UT Southwestern Medical Center
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DallasUnited StatesUnknown status
Texas Oncology P A 3
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DallasUnited StatesUnknown status
Parkland Health and Hospital System
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DallasUnited StatesUnknown status
Advanced Urology Institute
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Daytona BeachUnited StatesUnknown status
Urology Associates of Central California
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FresnoUnited StatesUnknown status
Central Ohio Urology Group
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GahannaUnited StatesUnknown status
The Conrad Pearson Clinic
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GermantownUnited StatesUnknown status
Urology of Indiana
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GreenwoodUnited StatesUnknown status
MSKCC Westchester
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HarrisonUnited StatesUnknown status
Urology Centers of Alabama
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HomewoodUnited StatesUnknown status
Houston Metro Urology
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HoustonUnited StatesUnknown status
Texas Oncology P A 2
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HoustonUnited StatesUnknown status
First Urology, PSC
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JeffersonvilleUnited StatesUnknown status
Advanced Urology Associates
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JolietUnited StatesUnknown status
Colorado Clinical Research
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LakewoodUnited StatesUnknown status
Arkansas Urology
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Little RockUnited StatesUnknown status
Helios Clinical Research, LLC
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Middleburg HeightsUnited StatesUnknown status
MSKCC Monmouth
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MiddletownUnited StatesUnknown status
MSKCC Bergen
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MontvaleUnited StatesUnknown status
Urology Associates
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NashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Virginia Oncology Associates
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NorfolkUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
VA Pittsburgh
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PittsburghUnited StatesUnknown status
Oncology and Hematology Associates of Southwest Virginia, Inc.
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RoanokeUnited StatesUnknown status
University of Utah - Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
Texas Oncology San Antonio Northeast
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San AntonioUnited StatesUnknown status
VA Medical Center
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San FranciscoUnited StatesUnknown status
Sansum Clinic Pharm
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Santa BarbaraUnited StatesUnknown status
Maryland Oncology Hematology P.A.
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Silver SpringUnited StatesUnknown status
Associated Medical Professionals
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SyracuseUnited StatesUnknown status
Northwest Cancer Specialists PC
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TigardUnited StatesUnknown status
Chesapeake Urology Research Associates
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TowsonUnited StatesUnknown status
Michigan Institute of Urology
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TroyUnited StatesUnknown status
Del Sol Research Management, LLC
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TucsonUnited StatesUnknown status
Arizona Urology Specialists
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TucsonUnited StatesUnknown status
MSKCC Nassau Regional Cancer Center
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UniondaleUnited StatesUnknown status
Urology Of Virginia, Pllc
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Virginia BeachUnited StatesUnknown status
Texas Oncology P A 1
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Wichita FallsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.