NRG-GU007

Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen DeprIvation Therapy (ADT) in High Risk Prostate Cancer (with Initial Phase I) (NADIR*)

Principal Investigator

Dror Michaelson

Status

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