Prostate cancer
EA8183
A Phase III Double Blinded Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis
Trial overview
Topic
EA8183
Disease
Prostate cancer
Description
Primary Objective:To determine whether 12 months (52 weeks) of androgen deprivation therapy (ADT) and darolutamide improves metastasis-free survival (MFS) compared to 12 months (52 weeks) of ADT plus placebo in men with high risk prostate cancer (defined by CAPRA-S score ≥3 and a high Decipher score (>0.6) (C3+D+)) who have undergone radical prostatectomy.