Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Localized disease treated with surgery only
• pT2, pT3, or pT4
• pN0 or pNx
• No clinical signs of progressive disease
• Prostate-specific antigen (PSA) meeting the following criteria:

• PSA ≤ 0.1 ng/mL after prostatectomy
• PSA ≥ 0.2 ng/mL and < 2 ng/mL at study entry

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy ≥ 10 years
• No other cancer in the past 5 years except for treated basal cell skin cancer
• No known pituitary gland adenoma
• No uncontrolled hypertension (i.e., blood pressure ≥ 160 mm Hg systolic and/or 90 mm Hg diastolic)
• No geographical, social, or psychological condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior hormonal therapy
• No prior pelvic radiotherapy
• No prior surgical or chemical castration
• At least 6 months since surgery for biological recurrence
• No other concurrent anticancer therapy