CHARLOTTE, N.C., Dec. 19 A Phase III clinical trial at New York University 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) using the Sonablate(R) 500.
Dr. Herbert Lepor, Chairman of Urology at NYU School of Medicine and medical monitor for the trial said, "HIFU using the Sonablate(R) 500 device is a very promising minimally invasive ablative therapy for both the treatment of recurrent prostate cancer following failed external beam radiation therapy and newly diagnosed localized prostate cancer."
Over 40,000 men with prostate cancer that are treated with radiation have their cancer return every year. These men have few options besides hormone therapy. According to the American Cancer Society possible side effects of hormone therapy include osteoporosis, anemia, loss of muscle mass, depression, decreased mental acuity and impotence.
HIFU with the Sonablate(R) is a minimally invasive, outpatient procedure that uses a transrectal probe to focus ultrasound energy to create a sharp increase in heat within the prostate, thus destroying the tissue. HIFU is radiation free and non surgical. In a small U.S. safety trial, 91% of the participants treated in the trial had a negative biopsy at 6 months.
"We are excited to add NYU to the list of clinical trial sites evaluating the Sonablate(R) 500 for the treatment of recurrent prostate cancer," said Steve Puckett, Jr., Chief Executive Officer, USHIFU, the company managing the clinical trials with sponsor Focus Surgery, Inc. "The existing treatment options for patients who have recurrent prostate cancer post radiation are limited and often associated with significant quality of life morbidity, so the potential for an alternative therapy is very exciting," Puckett continued.
Eligible participants for the trial must be between the ages of 40 and 80, have biopsy confirmed local recurrence two or more years following external beam radiation failure (EBRT) and meet several other selection criteria as well.
For more information about enrolling in the HIFU trial calls 1-877-874-4389 or visit www.ProstateCancerRecurrentTrial.org.
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.