Name of the Trial
Phase III Randomized Study of Hypofractionated Versus Conventionally Fractionated Three-Dimensional Conformal or Intensity-Modulated Radiotherapy in Patients with Favorable-Risk Stage II Prostate Cancer (RTOG-0415). See the protocol summary at http://cancer.gov/clinicaltrials/RTOG-0415.

Principal Investigator
Dr. W. Robert Lee, Radiation Therapy Oncology Group

Why This Trial Is Important
Radiotherapy is a standard treatment for prostate cancer. Typically, men with localized prostate cancer who undergo external-beam radiotherapy (as opposed to radioactive seed implants) are treated 5 days a week for 8- to 10-weeks, with only a fraction of the total prescribed radiation dose administered each day of treatment.

Some studies suggest that a conventional 8- to 10-week course of radiotherapy may not be the most effective or economical way of treating these patients. Consequently, researchers are studying whether increasing the dose of radiation during each day of treatment and delivering the total radiation dose over a shorter period of time (called hypofractionated radiotherapy) may be an equally effective approach to treating prostate cancer.

In this trial, men with favorable-risk, localized prostate cancer will be randomly assigned to receive conventionally fractionated radiation therapy over the course of about 8 weeks (41 daily treatments) or hypofractionated radiotherapy over a 5-and-a-half-week period (28 daily treatments).

"Previous studies of hypofractionated radiotherapy were not designed to tell us if the technique works as well as conventional regimens in terms of helping patients live longer without recurrence of their cancer," said Dr. Lee. "This trial is designed to answer that question."

"If we determine that we can deliver radiation over a shorter period of time with similar efficacy, we may realize benefits in terms of cost and convenience for patients as well."

Who Can Join This Trial
Researchers will recruit 1,067 men aged 18 or over with favorable-risk stage II prostate cancer. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/RTOG-0415.

Study Site and Contact Information
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites at http://www.cancer.gov/clinicaltrials/RTOG-0415 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.