Last updated on February 2011

MRI-Guided Radiation Therapy in Treating Patients With Prostate Cancer

Brief description of study

RATIONALE: Imaging procedures, such as MRI, may help the doctor find the exact location of the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an effective treatment for prostate cancer. 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: Primary - Determine the maximum tolerated dose of MRI-guided intensity-modulated external beam radiotherapy in patients with prostate cancer. Secondary - Correlate the radiation response to and/or toxicity of this regimen with genomic and proteomic analyses in these patients. - Determine the long-term effects and toxicity of this regimen after selective intra-prostatic dose escalation in these patients. OUTLINE: This is a dose-escalation study. Patients undergo MRI-guided intensity-modulated external beam radiotherapy over 10 minutes once daily 5 days a week for 8.5 weeks. Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy (to areas of histologically confirmed prostate cancer*) 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. NOTE: *Areas of the prostate with signal abnormality on MRI that cannot be biopsied or without definite histologic evidence of prostate cancer receive intermediate doses; all other areas of the prostate receive standard doses. After completion of study treatment, patients are followed at 2, 4, 8, and 12 weeks, 6, 9, 12, and 18 months, and then every 6 months for up to 5 years. PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 2 years.

Clinical Study Identifier: NCT00227799

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Recruitment Status: Open

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