OBJECTIVES:
Primary
* Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have undergone surgery for recurrent or refractory prostate cancer.
Secondary
* Compare overall survival of patients treated with these regimens.
* Compare metastases-free survival of patients treated with these regimens.
* Compare the immediate and delayed toxicities of these regimens.
* Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens.
* Compare the quality of life at 1 and 5 years after radiotherapy in these patients.
* Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.
OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
* Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin subcutaneously on day 1 and again 3 months later.
Quality of life is assessed periodically.
After completion of study therapy, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.
