Name of the Trial
Phase I Study of MRI-Guided Intensity-Modulated External-Beam Radiotherapy in Patients with Prostate Cancer (NCI-05-C-0191). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-05-C-0191.

Principal Investigator
Dr. Anurag Singh, NCI Center for Cancer Research

Why This Trial Is Important
An estimated 234,460 American men will be diagnosed with prostate cancer in 2006. Many of these men will undergo external-beam radiation therapy to treat their cancer.

In this study, doctors will use a new method called intensity-modulated external-beam radiation therapy (IMRT) to treat men with localized prostate cancer. Patients will undergo a magnetic resonance imaging (MRI) procedure, and doctors will use the resulting images to pinpoint areas of the prostate containing cancer cells. The presence of cancer in these areas will be confirmed with biopsies. Doctors will then treat the areas identified as cancerous with higher doses of radiation, while delivering a standard dose of radiation to the rest of the prostate and surrounding normal tissue.

"When treating prostate cancer, higher radiation doses have produced better outcomes," said Dr. Singh. "This trial is an attempt to use IMRT and MRI imaging, confirmed by MRI-guided biopsy, to direct much higher doses of radiation to those areas of the prostate containing tumor cells. The remainder of the prostate will receive standard radiation doses. This may allow us to more effectively treat the tumor without increasing toxicity to normal tissue."

With this phase I trial, researchers will study the side effects and determine the best dose of MRI-guided radiation therapy for treating patients with prostate cancer.

Who Can Join This Trial
Researchers will recruit up to 36 patients aged 18 to 89 with a confirmed diagnosis of prostate adenocarcinoma that has not spread to other parts of the body. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-05-C-0191.

Study Site and Contact Information
The study is taking place at the NIH Clinical Center in Bethesda, Md. For more information about this trial, call the NCI Clinical Studies Support Center toll free at 1-888-NCI-1937. This call is confidential.