NCT05884398

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Castrate-sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2023-08-31
• Primary completion: 2026-10-12
• Completion: 2028-10-12
• First posted: 2023-06-01
• Last updated: 2026-03-12

Locations

93 sites across 9 countries: United States, Australia, Brazil, Canada, China, France, Germany, Mexico, Poland

Regulatory

• FDA-regulated drug study