EA8183 (ERADICATE) – A Phase III Double Blinded Study of Early Intervention after Radical Prostatectomy with Androgen Deprivation Therapy with or without Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification

The majority of patients with prostate cancer have clinically localized or locoregional spread of their disease; most of them are cured by definitive local therapy. However, the subset of patients with high-risk features (Gleason grade 8-10, positive lymph nodes, or positive seminal vesicles) has a 50%-75% chance of disease recurrence within 10 ten years. Individuals in this high-risk group need better treatment options.

Curative treatment for clinically localized, high-risk prostate cancer often includes systemic treatment with androgen deprivation therapy (ADT) following prostatectomy. In some cases, pelvic radiation is also utilized. Despite these efforts, a significant proportion of patients will relapse and ultimately die of metastatic prostate cancer, presumably due to micrometastatic disease that remains. Thus, although ADT is routinely used in an effort to eradicate remaining disease, it remains inadequate for men at greatest risk of distant recurrence.

The EA8183 study is assessing whether the addition of the drug darolutamide to standard ADT will improve metastasis-free survival compared to ADT plus placebo in men with high-risk prostate cancer who have undergone radical prostatectomy. Darolutamide is an androgen receptor antagonist that is FDA approved to treat men with non-metastatic, castration-resistant prostate cancer. Previous studies have demonstrated the efficacy of potent androgen receptor antagonist activity in delaying disease progression, even in the setting of low testosterone.

This study is led by Alicia Morgans, MD, MPH (Northwestern University).

Other NCTN groups are collaborating on this trial through study champions. The groups and their champions are the ALLIANCE for Clinical Trials in Oncology, Russell Szmulewitz, MD (University of Chicago); NRG Oncology, Felix Feng, MD, PhD (University of California, San Francisco); and SWOG, Tanya Dorff, MD (City of Hope).

Learn more about ERADICATE at ecog-acrin.org.