Cryotherapy center to participate in HIFU clinical trial

May 8, 2008

EDAP TMS has announced that Atlantic Urology in Daytona Beach, FL, has received Institutional Review Board approval to participate in the company’s ongoing ENLIGHT phase II/III clinical trial of Ablatherm high-intensity focused ultrasound (HIFU) in patients with localized prostate cancer.

EDAP TMS has announced that Atlantic Urology in Daytona Beach, FL, has received Institutional Review Board approval to participate in the company’s ongoing ENLIGHT phase II/III clinical trial of Ablatherm high-intensity focused ultrasound (HIFU) in patients with localized prostate cancer.

“HIFU is an interesting new technology for the treatment of prostate cancer, as several centers in Europe have reported intriguing clinical outcomes,” said Martin Dineen, MD, one of 14 urologists at Atlantic Urology. “Atlantic Urology is proud to participate in the FDA-approved Investigational Device Exemption evaluation of HIFU. Our center draws upon a large population of elderly patients residing in central Florida, which should be very beneficial to our accrual efforts.”

The prospective non-inferiority study is designed to evaluate the safety and efficacy of the Ablatherm system versus cryotherapy for the treatment of low-risk, localized prostate cancer. The clinical trial is currently enrolling men over age 60 years diagnosed with clinical stage T1a, b, or c, or T2a localized prostate cancer. The primary outcome measure of the trial will be a statistically significant reduction and stability of PSA throughout a 24-month follow-up period.