The treatment results of patients with T3 prostate cancer with radiation therapy alone are disappointing. This is phase III, multicenter, non- blinded, randomized trial of NCID, CTG CUOG, ECOG, CALGB and SWOG evaluating possible benefits from the addition of external beam radiation therapy to the treatment of patients with locally advanced (T3 or T4 NO MO) cancer of the prostate who have not had a radical prostatectomy and are receiving hormone therapy. The primary endpoint is overall survival while also evaluating time to disease progression and the quality of life of patients. Patients will be stratified to two study arms. All patients will be treated by total androgen ablation. They have the choice of treatment either by bilateral orchiectomy with or without antiandrogen or by LHRH agonist with at least six weeks of antiandrogen. patients will be randomized to receive either total androgen ablation alone or total androgen ablation with radical radiation therapy. Participating centers will be randomized to one of the two quality of life instruments. This study will involve male subjects less than 80 years of age with locally advanced adenocarcinoma of the prostate. Patients must meet eligibility criteria as defined by the protocol. Pre-randomization quality of life assessments will be completed and subjects participating in the study must be willing to complete future assessments.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR005096-10A1
Application #
6265792
Study Section
Project Start
1999-07-19
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
10
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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