NRG-GU002: Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel
Principal Investigator
Mark Hurwitz, MD
Status
Closed to Accrual
Date Opened To Accrual
December 30 2016
Date Closed to Accrual
September 06 2022
Disease Site
Genitourinary [GU]
Prostate
Phase
II/III
Developmental Therapeutics
No
Primary Objective
To assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical prostatectomy
Patient Population
Pathologically proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy. Post prostatectomy Gleason ≥ 7, baseline PSA nadir ≥ 0.2 ng/ml. Surgical FFPE specimen must be submitted to GenomeDx for genomic analysis on DECIPHER GRID platform per Section 10 of the protocol.
Target Accrual
909
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.