Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer recurrent prostate cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 840
Healthy volunteers: no

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.

Detailed description:

Arms:
arm 1: Radiation therapy + bicalutamide arm 2: Radiation therapy + placebo

Interventions: intervention 1: bicalutamide intervention 2: radiation therapy intervention 3: placebo
Intervention descriptions: intervention 1: One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation. intervention 2: 64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra. intervention 3: One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

Protocol document: