Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 41 - Any |
| Updated: | 11/7/2018 |
| Start Date: | September 1995 |
| End Date: | September 2019 |
A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
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.
(hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer
would improve overall survival.
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.
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.
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
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