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Study of External Beam Radiation Therapy with and Without Hormonal Therapy to Treat Prostate Cancer - Article


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Clinical Trial: Study of External Beam Radiation Therapy with and Without Hormonal Therapy to Treat Prostate Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Dana-Farber Cancer Institute
Brigham and Women''''s Hospital
Saint Anne''''s Hospital
New England Deaconess Hospital
Metro West Medical Center
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00116220

Purpose

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 Intervention Phase
Prostate Cancer
  Drug: Flutamide (Eulexin)
 Drug: Leuprolide Acetate (Lupron)
 Drug: Goserelin Acetate (Zoladex)
 Phase III

MedlinePlus related topics:  Prostate Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: To determine freedom from PSA failure when adding total androgen suppression (TAS) to external beam radiation (RT)
Secondary Outcomes: Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy
Expected Total Enrollment:  270

Study start: September 1995

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.

Eligibility

Ages Eligible for Study:  41 Years and above,  Genders Eligible for Study:  Male
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:

Location Information


Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Anthony V D''''Amico, M.D. Ph.D.,  Principal Investigator,  Dana-Farber Cancer Institute   

More Information

Publications that report results of this study

D''''Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7.

Study ID Numbers:  95-096
Last Updated:  July 25, 2005
Record first received:  June 27, 2005
ClinicalTrials.gov Identifier:  NCT00116220
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02


Source: ClinicalTrials.gov
Cache Date: August 3, 2005

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Page Updated: June 1, 2005
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