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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00116220

Collaborator

Brigham and Women's Hospital (Other), Saint Anne's Hospital (Other), Beth Israel Deaconess Medical Center (Other), Metro West Medical Center (Other)

206

Enrollment

Location

Arms

233

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Flutamide (Eulexin) and Lupron or Zoladex Radiation: External Beam Radiotherapy	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1995

Actual Primary Completion Date :

Apr 1, 2001

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment 1 External beam radiation therapy + 6 months total androgen ablation	Drug: Flutamide (Eulexin) and Lupron or Zoladex Androgen suppression therapy Radiation: External Beam Radiotherapy Once a day, 4-5 days per week for approximately 2 months
Active Comparator: Treatment 2 External beam radiation therapy	Radiation: External Beam Radiotherapy Once a day, 4-5 days per week for approximately 2 months

Arm

Intervention/Treatment

Active Comparator: Treatment 1

External beam radiation therapy + 6 months total androgen ablation

Drug: Flutamide (Eulexin) and Lupron or Zoladex

Androgen suppression therapy

Radiation: External Beam Radiotherapy

Once a day, 4-5 days per week for approximately 2 months

Active Comparator: Treatment 2

External beam radiation therapy

Radiation: External Beam Radiotherapy

Once a day, 4-5 days per week for approximately 2 months

Outcome Measures

Primary Outcome Measures

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. [Years]