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First received: May 23, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Metastatic Castrate-sensitive Prostate Cancer

Study Type: INTERVENTIONAL


Official Title: 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 Castrat

Brief 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…

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