RTOG-1115

Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GNRH Agonist and TAK-700 For Men with High Risk Prostate Cancer

Principal Investigator

M. Dror Michaelson

Status

Disease Site

Genitourinary [GU] Prostate

Phase

III

Developmental Therapeutics

No

Primary Objective

To evaluate the difference in overall survival in men with clinically localized prostate cancer with unfavorable prognostic features between a) standard treatment (ADT + radiotherapy) and b) standard treatment with the addition of 24 months of TAK-700.

Patient Population

Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations:

Gleason score                      PSA                                 T-Stage
> 9                            and        < 150                  and          Any
8                               and        < 20                     and         > T2
8                               and         > 20-150            and         Any
7                               and         > 20-150            and         Any

 

Target Accrual

900