August 20, 2007 - EDAP TMS S.A., a provider of High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer, 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.
"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.