Last updated on February 2011

MRI-Guided Radiation Therapy in Treating Patients With Prostate Cancer

Brief description of study

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. PURPOSE: This phase I trial is studying the side effects and best dose of MRI-guided radiation therapy in treating patients with prostate cancer.

Detailed Study Description

OBJECTIVES: - 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.

Clinical Study Identifier: NCT00278356

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Recruitment Status: Open

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