Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I)
Principal Investigator
Dror Michaelson, MD PhD
Status
Closed to Accrual
Date Opened To Accrual
June 03 2019
Date Closed to Accrual
July 01 2024
Disease Site
Genitourinary [GU]
Prostate
Phase
I/II
Developmental Therapeutics
Yes
Primary Objective
Phase I: To establish the preferred dose of niraparib in combination with radiation and ADT
Phase IIR: To compare the disease-free state, defined as PSA remaining < 0.1 ng/ml at the end of ADT therapy in men with high risk prostate cancer treated with standard therapy with or without the addition of niraparib
Patient Population
Histologically confirmed adenocarcinoma of prostate at high risk for recurrence determined by Gleason score
Target Accrual
180
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.