A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
Overview
- Phase
- Phase 3
- Intervention
- Flutamide (Eulexin) and Lupron or Zoladex
- Conditions
- Prostate Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Anthony V. D'Amico, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility 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
Arms & Interventions
Treatment 1
External beam radiation therapy + 6 months total androgen ablation
Intervention: Flutamide (Eulexin) and Lupron or Zoladex
Treatment 1
External beam radiation therapy + 6 months total androgen ablation
Intervention: External Beam Radiotherapy
Treatment 2
External beam radiation therapy
Intervention: External Beam Radiotherapy
Outcomes
Primary Outcomes
To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone.
Time Frame: Years
Secondary Outcomes
- Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy(Years)