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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: External Beam Radiotherapy; Drug: Flutamide (Eulexin) and Lupron or Zoladex

• Registration Number: NCT00116220
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1995-09
• Primary Completion: 2001-04
• Study First Submitted: 2005-06-27
• Study First Submitted QC: 2005-06-27
• Study First Posted: 2005-06-28
• Study Completion: 2015-02
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 206

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

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Exclusion Criteria

• Prior history of malignancy
• Prior hormonal therapy or chemotherapy
• Prior pelvic radiation therapy
• Unable to tolerate lying still 5-10 minutes/day

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 2	External Beam Radiotherapy	External beam radiation therapy
Treatment 1	Flutamide (Eulexin) and Lupron or Zoladex	External beam radiation therapy + 6 months total androgen ablation
Treatment 1	External Beam Radiotherapy	External beam radiation therapy + 6 months total androgen ablation

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy	Years

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States