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

Running, not enrolling · Phase 3

Conditions studied: Metastatic Castrate-sensitive Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05884398

Run by

Janssen Research & Development, LLC

People needed

420

Starts

2023-08-31

Expected to finish

2028-10-12

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Del Sol Research Management, LLC — Tucson, Arizona, 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
• Urology Centers Of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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