Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
This trial is active, not recruiting.
|Treatments||flutamide (eulexin) and lupron or zoladex, external beam radiotherapy|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy
time frame: Years
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
|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.|
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