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U.S. HIFU LLC Release: High Energy HIFU Gives Hope For Prostate Cancer Radiation Failure


5/17/2006 10:39:09 AM

CHARLOTTE, N.C., May 16 /PRNewswire/ -- A Clinical study for locally recurrent prostate cancer following radiation failure with High Intensity Focused Ultrasound (HIFU) using the Sonablate(R) 500 (Focus Surgery, Inc., Indianapolis, IN) is now enrolling patients at the London Health Sciences Centre in London, Ontario. The purpose of the study, led by investigator Joseph Chin, MD, is to determine the ability of HIFU to destroy prostate cancer tissue in patients with local recurrence after radiation failure.

Radiation is one of the traditional treatment modalities for patients with localized prostate cancer. However, a proportion of these treatments fail and the cancer comes back, or recurs, and patients must explore further treatment options, also known as salvage treatments.

The options for managing recurrent prostate cancer include cryoablation, salvage prostatectomy and hormone therapy. Unfortunately, hormone ablation is non-curative and while surgery and cryoablation could be curative, both can lead to potentially serious side effects.

HIFU with Sonablate(R) 500 may offer men with recurrent prostate cancer a minimally invasive treatment option with less risk and fewer side effects than traditional treatment modalities. Unlike radiation, HIFU is non-ionizing; therefore it will not weaken cells and surrounding anatomy that may have already been damaged during radiation therapy. Also, HIFU is less invasive because it is applied from outside the prostate while cryoablation requires several needles to be placed directly in the prostate gland. In addition, HIFU is a one-time procedure performed on an out-patient basis.

"With my experience in salvage prostate cancer cryoablation following radiation failure, HIFU is a logical next step for me in a search for an even less invasive treatment modality which is effective and most important of all, safe. This phase II trial takes a critical look at the efficacy, tolerability and the complication rates of HIFU. We hope to either verify or refute its claim as an effective, minimally invasive salvage option," Chin said.

Only men who have had radiation treatment in the past, either external beam radiation therapy or brachytherapy, and now have biopsy-proven local recurrence will be considered as participants in the study. Men must also be between the ages of 40 and 80 with a prostate specific antigen (PSA) between .5 ng/ml and 10 ng/ml and a Gleason score of eight or less. If a person qualifies for the study, there will be no charge to enroll for treatment in the study.

HIFU is a targeted, precise treatment approach that uses sound waves to rapidly heat and destroy targeted tissue in a matter of seconds.

An article by Toyoaki Uchida in the British Journal of Urology illustrates that HIFU is already being used as an effective primary treatment option for localized prostate cancer in Europe and Japan with 87 percent of patients treated cancer-free after three years.

The Sonablate(R) 500, developed by Focus Surgery Inc. and manufactured by Misonix, Inc. of Farmingdale, NY, is the only HIFU device in Canada that can treat prostates with height dimensions greater than 25 mm and does not require a preliminary transurethral resection of the prostate (TURP), which is a surgical procedure. There are nearly 100 Sonablate(R) 500 HIFU Centers worldwide where more than 5,000 HIFU procedures have been completed on six continents.

HIFU with the Sonablate(R) 500 for localized prostate disease is already available in private clinics in Windsor and Toronto, Ontario. For more information please call 1-888-874-4384 or visit http://www.internationalhifu.com.

Although the Sonablate(R) 500 does not yet have United States FDA approval, the next phase of clinical trials for localized prostate cancer is expected to begin soon. An FDA approved safety trial for locally recurrent prostate cancer is already enrolling patients.

U.S. HIFU LLC

CONTACT: Amanda Willis of USHIFU, LLC, +1-704-332-4308, oramandawillis@ushifu.com



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