Status:
COMPLETED
Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Saint Anne's Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
41+ years
Phase:
PHASE3
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 overa...
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 mo...
Eligibility Criteria
Inclusion
- 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
- Prior history of malignancy
- Prior hormonal therapy or chemotherapy
- Prior pelvic radiation therapy
- Unable to tolerate lying still 5-10 minutes/day
Key Trial Info
Start Date :
September 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00116220
Start Date
September 1 1995
End Date
February 1 2015
Last Update
January 6 2022
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115