• Progression-free (biological and/or clinical) survival [ Designated as safety issue: No ]
  

• Overall survival [ Designated as safety issue: No ]
  
• Metastases-free survival [ Designated as safety issue: No ]
  
• Immediate and delayed toxicities [ Designated as safety issue: Yes ]
  
• Delay in reaching the prostate-specific antigen nadir [ Designated as safety issue: No ]
  
• Quality of life at 1 and 5 years after radiotherapy [ Designated as safety issue: No ]
  
• Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Designated as safety issue: No ]
  

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