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
- Diseases
- Prostate cancer
- 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
Sites (91)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Macquarie University Hospital Coordinator of this site? Confirm its status | Macquarie University | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Mater Misericordiae Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Fundacao Pio XII Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Hospital das Clínicas - Universidade Federal de Minas Gerais Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Ministerio da Saude Instituto Nacional do Cancer Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| IDOR - Regional Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Southern Alberta Institute of Urology / Prostate Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Sunnybrook Health Sciences Center Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China School of Medicine/West China Hospital, Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Nanfang Hospital of Southern Medical Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Active, not recruiting |
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Active, not recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Studienpraxis Urologie Coordinator of this site? Confirm its status | Nürtingen | Germany | Active, not recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| SCIENTIA Investigacion Clinica SC Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Consultorio de Especialidad en Urologia Privado Coordinator of this site? Confirm its status | Durango | Mexico | Unknown status |
| Medical Care & Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Cuidados Oncologicos Coordinator of this site? Confirm its status | Querétaro | Mexico | Unknown status |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Polimed Specjalistyczna Przychodnia Lekarska Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Texas Oncology P A Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Centers for Advanced Urology LLC d b a MidLantic Urology Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Unknown status |
| MSKCC Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Associated Urological Specialists LLC Coordinator of this site? Confirm its status | Chicago Ridge | United States | Unknown status |
| TriState Urologic Services PSC Inc. DBA The Urology Group Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| MSKCC @ Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Texas Oncology P A 3 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Parkland Health and Hospital System Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Advanced Urology Institute Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| Urology Associates of Central California Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Central Ohio Urology Group Coordinator of this site? Confirm its status | Gahanna | United States | Unknown status |
| The Conrad Pearson Clinic Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Urology of Indiana Coordinator of this site? Confirm its status | Greenwood | United States | Unknown status |
| MSKCC Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Urology Centers of Alabama Coordinator of this site? Confirm its status | Homewood | United States | Unknown status |
| Houston Metro Urology Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Texas Oncology P A 2 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| First Urology, PSC Coordinator of this site? Confirm its status | Jeffersonville | United States | Unknown status |
| Advanced Urology Associates Coordinator of this site? Confirm its status | Joliet | United States | Unknown status |
| Colorado Clinical Research Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Arkansas Urology Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Helios Clinical Research, LLC Coordinator of this site? Confirm its status | Middleburg Heights | United States | Unknown status |
| MSKCC Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| MSKCC Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Urology Associates Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| VA Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oncology and Hematology Associates of Southwest Virginia, Inc. Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| University of Utah - Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Texas Oncology San Antonio Northeast Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| VA Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Sansum Clinic Pharm Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| Associated Medical Professionals Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Northwest Cancer Specialists PC Coordinator of this site? Confirm its status | Tigard | United States | Unknown status |
| Chesapeake Urology Research Associates Coordinator of this site? Confirm its status | Towson | United States | Unknown status |
| Michigan Institute of Urology Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Del Sol Research Management, LLC Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Arizona Urology Specialists Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| MSKCC Nassau Regional Cancer Center Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
| Urology Of Virginia, Pllc Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| Texas Oncology P A 1 Coordinator of this site? Confirm its status | Wichita Falls | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.