Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments flutamide (eulexin) and lupron or zoladex, external beam radiotherapy
Phase phase 3
Sponsor Dana-Farber Cancer Institute
Collaborator Brigham and Women's Hospital
Start date September 1995
End date April 2001
Trial size 226 participants
Trial identifier NCT00116220, 95-096

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
External beam radiation therapy + 6 months total androgen ablation
flutamide (eulexin) and lupron or zoladex
Androgen suppression therapy
external beam radiotherapy
Once a day, 4-5 days per week for approximately 2 months
(Active Comparator)
External beam radiation therapy
external beam radiotherapy
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.
time frame: Years

Secondary Outcomes

Measure
Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy
time frame: Years

Eligibility Criteria

Male participants at least 41 years old.

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

Additional Information

Official title A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
Principal investigator Anthony V D'Amico, M.D. Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.