Prostate Cancer Clinical Study Resumes At Virginia Urology Center

Armen Hareyan's picture

EDAP TMS S.A. announced the continuation of its US Phase II/III clinical trial with treatment of an additional two patients at Virginia Urology Center, Richmond, Virginia.

Anthony Sliwinski, MD, and David Miller, MD, are leading the study at the site.


We continue to work with our centers accelerating recruitment of patients eligible to participate in this important study of a new but well documented method for treating localized prostate cancer," said Marc Oczachowski, CEO of EDAP. "Ablatherm-HIFU has a 10-year record of successful outcomes and low side effects with significant clinical studies already published. We are pleased these centers in the US are helping bring forward the necessary clinical work to make these benefits available to US patients in the future. We are working closely with all centers and adding new sites."

"We were very excited when approached with this opportunity," said Sliwinski. "We are a highly motivated practice when it comes to the care of our patients. We have our own Research Department here at Virginia Urology, and are always interested in pursuing projects that may lead to a better quality of life. HIFU presented such an opportunity. The EDAP Ablatherm-HIFU equipment is very easy to use. The ultrasound technology and safety features of the equipment make my part effortless. Thus far, we have treated four men using this technology. Our first two patients had a very positive experience and an immediate reduction in their PSA results. Both men have been enthusiastic spokesmen for this procedure. Our most recent treatments lasted shortly over two hours and immediate results seem excellent. This procedure appears to be a wonderful alternative to the many current treatment options for prostate cancer."

The study is currently enrolling men over age 50 diagnosed with clinical stage T1a, b or c or T2a localized prostate cancer. HIFU is a noninvasive therapy using highly focused ultrasound energy to ablate the prostate tissue.

"While seeking US approval, Ablatherm-HIFU continues its steady advance in Europe where EDAP is the recognized dominant HIFU provider based on clear consensus of the medical community that this therapy is a good selection for nonsurgical patients," said Oczachowski. "We see positive ongoing response to the rollout of Ablatherm-HIFU in major European markets with strong expectations for treatment growth as these education efforts progress. We are clearly committed to significant treatment increases under EDAP's industry leading Revenue Per Procedure program making HIFU therapy rapidly accessible to any center wishing to offer this key option to their patients."