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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Imaging procedures, such as MRI, may help the doctor send x-rays directly to the tumor and nearby lymph nodes and cause less damage to normal tissue.
- Determine the feasibility of treating the pelvic lymph nodes in patients with prostate cancer treated with intensity-modulated radiotherapy (IMRT).
- Determine the maximum tolerated dose of IMRT in these patients.
- Determine long term effects and toxicity in patients treated with IMRT.
OUTLINE: This is a pilot, dose-escalation study.
After pathology is available and 2 months of neoadjuvant hormone therapy is complete, patients undergo MRI-guided intensity-modulated radiotherapy (IMRT) to the at-risk or positive lymph nodes 5 days a week for 8.5 weeks.
Cohorts of 3-6 patients receive escalating doses of IMRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Primary Purpose: Treatment
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:46:39-0400
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