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)
Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS) — From randomization (Day 1 of Cycle 7) up to 18 months rPFS is defined as the duration from the date of randomization to the date of first documentation of confirmed radiographic progressive disease or death due to any cause, whichever occurs first. rPFS will be assessed by investigators using conventional imaging (computed tomography \[CT\]/magnetic resonance imaging \[MRI\] and 99mTc bone scans).
Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months — From randomization (Day 1 of Cycle 7) up to 18 months Severity adjusted hot flash score will be calculated from the hot flash diary which will be daily filled by the participants.
Trial sites (93)
Facility
City
Region
Status
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
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.
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