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Site for EA8183 A Phase III 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) (PSCI# 21-122)

This study is being done to answer the following question: Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patient must be = 18 years of age.
Patient must have undergone a radical prostatectomy (RP) and must be preregistered to Step 0 of this study at least 6 weeks after but not more than 12 weeks after their radical prostatectomy.
Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer.
Patient must have an ECOG performance status of 0-2.
Exclusion Criteria:
Patient must not have pathologic evidence of pelvic lymph node involvement.
Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure).
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Hershey, PA