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High Intensity Focused Ultrasound for Locally Recurrent Prostate Cancer Following External Beam Radiation Therapy Investigated in Phase III Clinical Study

CHARLOTTE, N.C., Sept. 11 /PRNewswire/ -- In a new study, men with locally recurrent prostate cancer may be able to receive a promising investigational ultrasound treatment option.

A Phase III clinical trial at Specialists in Urology, located in North Naples, FL, is investigating the safety and efficacy of High Intensity Focused Ultrasound (HIFU) for the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT). HIFU is a minimally invasive procedure that uses ultrasound energy to destroy cancerous tissue with focused sound waves.

The lead investigator of this trial site is Dr. Nicholas Franco. This is one of several trial sites in the nation approved by the Food and Drug Administration to participate in the trial, which will begin enrolling patients in September.

HIFU is intended to eliminate cancer by elevating tissue temperatures to more than 195 degrees Fahrenheit in a matter of seconds. The Sonablate(R) 500, the therapeutic ultrasound device, which will be used in the study, is designed to destroy the entire gland in one procedure without causing damage to tissue around the prostate.

Eligible participants for the trial must be between the ages of 40 and 80, have biopsy confirmed local recurrence two or more years following EBRT, confined prostate cancer with a prostate specific antigen (PSA) greater than or equal to .5 ng/mL and less than or equal to 10 ng/mL and a Gleason score of less than or equal to seven.

For more information about enrolling in the HIFU trial, call 1-877-874-4389, or visit

This investigational treatment is performed on an outpatient basis. Potential risks of the treatment include frequency, urgency, mild discomfort or discharge in urinary stream. Less common side effects may also include urinary stricture, retention, incontinence, impotence and rectal fistula.

Prostate cancer is the most common type of non-skin cancer in American men and the second leading cause of cancer deaths in men. The American Cancer Society estimates that there were about 234,460 new cases of prostate cancer in the U.S. in 2006 and that 27,350 men die annually from the disease.

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