NRG-GU002

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or Without Adjuvant Docetaxel

Principal Investigator

Mark Hurwitz

Status

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