Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer

A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer

This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.

This was a randomized study comparing external beam radiation therapy with total androgen ablation for 6 months with radiation therapy alone. Drugs were given 2 months prior, 2 months during, and 2 months after radiation therapy. Eulexin and Lupron or Zoladex was used in this study.

Inclusion Criteria:

• Biopsy proven prostate cancer
• Negative bone scan
• Lymph nodes by CT or MRI
• Adequate blood work
• Performance Status - ECOG 0-1
• Life expectancy of at least 10 years
• >40 years of age

Exclusion Criteria:

• Prior history of malignancy
• Prior hormonal therapy or chemotherapy
• Prior pelvic radiation therapy
• Unable to tolerate lying still 5-10 minutes/day