Centers Nationwide Participating In Clinical Trial To Determine Effectiveness Of High-Intensity Focused Ultrasound Procedure For Prostate Cancer

Main Category: Prostate / Prostate Cancer
Also Included In: MRI / PET / Ultrasound;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 16 Dec 2008 - 0:00 PST

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EDAP Technomed, Inc. announces the launch of a phase II/III clinical trial evaluating the effectiveness of a non-invasive medical device designed to target and treat prostate cancer with high-intensity focused ultrasound (HIFU). The ENLIGHT study is a multi-center clinical trial evaluating the safety and effectiveness of the Ablatherm® Integrated Imaging system compared with cryotherapy for the treatment of low-risk, localized prostate cancer. More information about the ENLIGHT study can be found at http://www.PCaResearch.com.

In the United States, prostate cancer is the second leading cause of cancer death in men after lung cancer, accounting for about 10 percent of all cancer-related deaths in men. The disease is more prevalent among African Americans, who have an annual incidence rate that is 60 percent higher than that of white men. African American men also have a 50 percent higher mortality rate. However, when prostate cancer is caught and treated early, the cure rate is greater than 90 percent, according to the Prostate Cancer Foundation.

Ablatherm uses ultrasound to detect the prostate and target the volume to be treated. The probe delivers HIFU energy throughout the prostate until it has been completely treated. The procedure is performed on an outpatient basis and takes approximately an hour and a half to three hours. Patients generally are mobile and can return to a normal routine within a few days of treatment.

"Less invasive options offer more convenience, less scarring, and faster recovery times than conventional treatments," said Dr. John Rewcastle, Medical Director / FDA Trials with EDAP Technomed. "Our goal with the ENLIGHT study is to determine the effectiveness of a non-invasive treatment that is convenient and effective in preventing the growth of prostate cancer."

Previous studies of this form of HIFU treatment conducted among men with low-risk cancer in Europe have shown negative biopsy rates ranging from 82 [1] to 93 [2] percent. Approximately 13,000 men have been treated to-date with HIFU worldwide. The most common side effects with the form of HIFU used in this study are similar to those experienced when undergoing cryotherapy: impotence, incontinence, pelvic pain and scrotal swelling.

1 Registered trademark of EDAP.

The ENLIGHT trial is being conducted at research centers in the United States and Canada. The study is seeking 410 patients aged 60 or older with a diagnosis of clinical stage T1a, b, or c, or T2a organ-confined prostate cancer confirmed by PSA and prostate biopsy.

About ENLIGHT

ENLIGHT is a North American clinical research study investigating the effectiveness of a medical device designed to target and deliver high-intensity focused ultrasound (HIFU) energy to the prostate, resulting in thermal deconstruction of prostate tissue. The ENLIGHT trial is a multi-center, phase II/III study evaluating the Ablatherm® Integrated Imaging HIFU system as compared with cryotherapy, a standard procedure, for the treatment of low-risk, localized prostate cancer.

About the Study Sponsor

The ENLIGHT clinical research trial is sponsored by EDAP Technomed, Inc. EDAP Technomed, Inc. markets the Ablatherm® Integrated Imaging system world wide including France, Germany, Italy and the United Kingdom for treatment of patients with newly diagnosed localized prostate cancer or who have failed radiotherapy treatment. Ablatherm-HIFU treatment is currently being evaluated in phase II/III testing in the United States and Canada, but does not have regulatory approval in the United States. The company is developing this technology for the potential treatment of other types of tumors. EDAP Technomed, Inc. also produces and commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).

References

[1] Chaussy et al Curr Urol Rep. 2003;4(3):248-52;
[2] Blana et al Urology. 2004;63(2):297-300;

http://www.PCaResearch.com