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Protocol Summary


Protocol No.
PSCI-21-122
Prinicipal Investigator
Traughber, Bryan
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
EA8183
Title
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 by Genomic Stratification (ERADICATE)
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.
Applicable Disease Sites
Prostate
Status
Open
Participating Institutions
Hershey Medical Center