Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-21-195
Prinicipal Investigator
Joshi, Monika
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
BTCRC-GU19-404
Title
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.
Applicable Disease Sites
Prostate
Status
Open
Participating Institutions
Hershey Medical Center