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Clinical Trials in Canada / NCT05884398
Active, not recruiting Phase 3

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

NCT05884398 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2023-08-31
Last updated
2026-09-25

Condition(s) studied

Metastatic Castrate-sensitive Prostate Cancer

Investigational drug(s) / intervention(s)

Apalutamide →Androgen-deprivation Therapy (ADT)

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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * History of seizure or known condition that has been determined to significantly predispose to seizure per investigator * 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

Primary outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
Urology Centers Of Alabama Homewood Alabama
Del Sol Research Management, LLC Tucson Arizona
Arizona Urology Specialists Tucson Arizona
Arkansas Urology Little Rock Arkansas
Urology Associates of Central California Fresno California
VA Medical Center San Francisco California
Sansum Clinic Pharm Santa Barbara California
Colorado Clinical Research Lakewood Colorado
Advanced Urology Institute Daytona Beach Florida
Associated Urological Specialists LLC Chicago Ridge Illinois
Advanced Urology Associates Joliet Illinois
Urology of Indiana Greenwood Indiana
First Urology, PSC Jeffersonville Indiana
Maryland Oncology Hematology P A Silver Spring Maryland
Chesapeake Urology Research Associates Towson Maryland
Michigan Institute of Urology Troy Michigan
MSKCC Basking Ridge Basking Ridge New Jersey
MSKCC Monmouth Middletown New Jersey
MSKCC Bergen Montvale New Jersey
MSKCC Commack Commack New York
MSKCC Westchester Harrison New York
Columbia University Medical Center New York New York
Memorial Sloan Kettering Cancer Center New York New York
Associated Medical Professionals Syracuse New York
MSKCC Nassau Regional Cancer Center Uniondale New York
TriState Urologic Services PSC Inc. DBA The Urology Group Cincinnati Ohio
Central Ohio Urology Group Gahanna Ohio
Helios Clinical Research, LLC Middleburg Heights Ohio
Northwest Cancer Specialists PC Tigard Oregon
Centers for Advanced Urology LLC d b a MidLantic Urology Bala-Cynwyd Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
VA Pittsburgh Pittsburgh Pennsylvania
The Conrad Pearson Clinic Germantown Tennessee
Urology Associates Nashville Tennessee
Texas Oncology P A Austin Texas
Parkland Health and Hospital System Dallas Texas
Texas Oncology P A 3 Dallas Texas
UT Southwestern Medical Center Dallas Texas
Texas Oncology P A 2 Houston Texas
Houston Metro Urology Houston Texas

+ 53 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05884398 on ClinicalTrials.gov ↗ ← All trials in Canada