Study Combines HIFU, Chemotherapy For Localized Prostate Cancer

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EDAP TMS is currently conducting clinical investigations in France under an approved clinical trial combining the company's Ablatherm-HIFU device with chemotherapy using docetaxel.

The study is a primary treatment therapy program for men suffering from clinically localized but aggressive high risk prostate cancer typically classified as stage T2c. The study began in late 2006 and will enroll a total of 30 men, of which more than 10 have already been treated.

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"Combination therapy is well documented as a treatment protocol for men suffering more aggressive prostate cancers," said Dr. Albert Gelet, Edouard Herriot Hospital, Lyon. "Ablatherm-HIFU is a proven effective treatment for localized prostate cancer already with strong clinical support. This study aims to evaluate its use under an additional dedicated protocol for men in the T2c cancer stage where the tumors are known to be more aggressive, creating a higher risk of relapse if the patient is treated with only a localized therapy. It was demonstrated in pre-clinical studies that HIFU improves chemotherapy drug efficacy in the area around burned tissues."

Under the approved protocol by French Ethical Committee, patients are administered a dose of docetaxel 30 minutes prior to a standard primary indication HIFU session lasting an average of two hours. The Ablatherm-HIFU ablates the prostate tissue according to conventional procedures and protocols. All treatments are administered at Edouard Herriot Hospital in Lyon, France.

"EDAP has a strong scientific and clinical base underlying the Ablatherm-HIFU, with constant work to enhance and extend the capabilities of the device," said Pr John Rewcastle, Medical Director for EDAP. "With already well documented specialized protocols for primary therapy, HIFU retreatment and salvage therapy following radiation failure, EDAP offers patients and physicians a statistical consistency of outcomes unmatched by traditional therapies. We intend to document the strength of Ablatherm-HIFU not only as a standalone focal treatment, but also in combination with other choices, giving doctors an enhanced arsenal in the fight against prostate cancer while preserving patient quality of life."

"EDAP continues to expand its market opportunity through rigorous and consistent clinical evaluation of the Ablatherm-HIFU system," said Marc Oczachowski, CEO of EDAP. "This test demonstrates the opportunity for Ablatherm to work in concert with other therapies for higher risk patients, expanding the potential population for whom Ablatherm-HIFU may be a solution."

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