Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

• Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]
  

• Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]
  
• Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]
  
• Local control as measured by Gray scale every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]
  
• Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy [ Designated as safety issue: Yes ]
  
• Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter [ Designated as safety issue: Yes ]
  
• Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the potential beneficial impact of radiotherapy with or without adjuvant bicalutamide and goserelin on the long-term outcome of patients with localized prostate cancer.
• Compare the acute and late radiation-induced side effects of these regimens in these patients.
• Compare the biochemical/clinical disease-free survival, overall survival, and time to local progression in patients treated with these regimens.
• Compare the time to clinical biological failure or death in patients treated with these regimens.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for 7-7.5 weeks.
• Arm II: Patients receive adjuvant oral bicalutamide once daily on days 1-30 and goserelin subcutaneously on days 8 and 98. Beginning on day 8, patients undergo radiotherapy as in arm I.

Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 5 years.