BTCRC-GU19-404 -A Single Arm, Phase I/II Trial of Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men with Localized, High Risk Prostate Cancer
Objective
Primary Objective: To estimate the efficacy of neoadjuvant androgen deprivation, darolutamide, and ipatasertib in men with previously untreated, localized, high-risk prostate cancer that is lacking PTEN, as measured by the pathological complete response or minimal residual disease.
Secondary Objectives: To assess the toxicity profile of androgen deprivation, darolutamide, and ipatasertib in men with high risk, localized, hormone sensitive prostate cancer that is lacking PTEN To measure 2 year biochemical recurrence-free survival (PSA ≤ 0.2 ng/mL) in men with high risk, localized, prostate cancer that is lacking PTEN. To measure rate of PSA0 (undetectable PSA with testosterone recovery and no additional therapy) in men with high risk, localized, prostate cancer that is lacking PTEN.
