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

• Status: Not yet recruiting
• Trial end date: 2027-05-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) provides non-inferior radiographic progression-free survival (rPFS) measured by 18-month event-free survival rate and reduce the burden of hot flash measured as 18-month percent change in severity adjusted hot flash score for participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached prostate-specific antigen (PSA) level at less than (<) 0.2 nanogram/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Androgens

Criteria

Inclusion Criteria:

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

• 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 equal (>=) 2 distinct extraprostatic sites of metastasis

• 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)

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