Trial Information

A PHASE III TRIAL OF THE STUDY OF ENDOCRINE THERAPY USED AS A CYTOREDUCTIVE AND CYTOSTATIC AGENT PRIOR TO RADIATION THERAPY IN GOOD PROGNOSIS LOCALLY CONFINED ADENOCARCINOMA OF THE PROSTATE

OBJECTIVES: I. Compare the overall and disease-specific survival and local and/or distant
clinical relapse rate in patients with locally confined carcinoma of the prostate treated
with goserelin plus flutamide used as cytoreductive agents prior to definitive radiotherapy
vs radiotherapy alone. II. Compare these regimens in terms of freedom from prostate specific
antigen (PSA) failure, second clinical relapse, and second PSA relapse in these patients.
III. Compare prostate rebiopsy results in these patients at 2 years. IV. Determine the
effect of goserelin and flutamide therapy on sexual function in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by PSA level (less
than 4 vs 4-20), tumor differentiation (good vs moderate vs poor), nodal status (N0 vs Nx),
and participating center. Patients are randomized to one of two treatment arms. Arm I:
Patients receive oral flutamide 3 times a day and goserelin subcutaneously once every 4
weeks, or once as a time release injection (intramuscular leuprolide may be substituted for
goserelin), beginning 2 months prior to radiotherapy and continuing until completion of
radiotherapy. Patients undergo radiotherapy daily 4-5 days per week for almost 8 weeks. Arm
II: Patients undergo radiotherapy only, as in arm I. Patients are followed every 3 months
for the remainder of the first year, every 4 months for 1 year, every 6 months for 3 years
and then annually thereafter.

PROJECTED ACCRUAL: A total of 1980 patients will be accrued for this study within 5 years.