Completed
PHASE3
INTERVENTIONAL
NCT00116220
Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
Flutamide (Eulexin) and Lupron or Zoladex
Type:
DRUG
Description:
Androgen suppression therapy
Name:
External Beam Radiotherapy
Type:
RADIATION
Description:
Once a day, 4-5 days per week for approximately 2 months
Primary Outcomes
Measure:
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.
TimeFrame:
Years
Description:
Trial Information
NCT ID
NCT00116220
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Dana-Farber Cancer Institute
Last Updated
December 15, 2025