Trial Information

A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE

OBJECTIVES:

- Compare overall survival following radiotherapy with or without bicalutamide in
patients with an elevated prostate-specific antigen (PSA) and no evidence of metastatic
disease following radical prostatectomy for pathologic T3 N0 prostate cancer.

- Compare each regimen with respect to time to second PSA-based progression, time to
distant failure, disease-specific survival, and non-disease-specific survival in this
patient population.

- Compare each regimen with respect to time to third PSA failure (or PSA progression on
hormone therapy for second PSA failure) as a potential predictor for impending cancer
death in these patients.

- Compare each regimen with respect to 5-year and 10-year freedom from progression rates.

- Compare each regimen with respect to unintended adverse effects on treatment.

- Allow for subsequent analysis of emerging molecular pathologic predictors of outcome
with the prospective collection of paraffin blocks from the radical prostatectomy
specimen.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified by
neoadjuvant hormone therapy, surgical (inked) margin status, PSA nadir after surgery, PSA
level at entry, and participating center.

All patients undergo radiotherapy to the original prostate volume, tumor resection bed, and
proximal membranous urethra over 7.2 weeks. Beginning immediately upon or just prior to the
initiation of radiotherapy, patients are randomized to receive either bicalutamide or
placebo daily for 2 years.

Recommended treatment for patients with increasing PSA and bone metastases consists of
maximal androgen blockage with a combination of orchiectomy or LHRH analogues plus
bicalutamide or flutamide.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 810 patients will be accrued for this study within
approximately 3 years.