HomeTrialNCT05884398
🔬NCT05884398Phase 3ACTIVE NOT RECRUITING

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

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.

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Study Details
Enrollment420 participants
Primary Completion
Lead SponsorJanssen Research & Development, LLC
Data Retrieved2026-04-11 02:55:31.550894+00:00
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