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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Metro West Medical Center; Saint Anne's Hospital
• Treatments: Androgens; Flutamide; Goserelin

Criteria

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