EDAP TMS SA, the global leader in therapeutic ultrasound, announced today that new, 10-year data from an international registry-based multi-center study shows 83 percent of patients had no biopsy evidence of disease after treatment with Ablatherm® HIFU. Study results were presented at the American Urological Association (AUA) 2011 Annual Meeting in Washington, D.C.
The largest, long-term study ever presented on high-intensity focused ultrasound (HIFU) reported outcomes from 2,552 patients treated throughout Europe, where Ablatherm-HIFU is currently available. Patients diagnosed with stage T1-T3 prostate cancer with low, moderate or high risk for disease progression were treated. Outcomes were followed using a secure online registry database, which tracked progression as measured by prostate-specific antigen (PSA) levels and prostate biopsy data.
The study revealed cancer cells could no longer be detected by a prostate biopsy in 83 percent of patients across all risk levels (low 89%, moderate 81%, high 78%). Consistent with previous HIFU studies, patients also experienced a mild side-effect profile. Ablatherm- HIFU is a fully automated, incision and radiation-free procedure that uses focused ultrasound waves to destroy cancerous tissue within the prostate, while protecting surrounding healthy tissue. Ablatherm-HIFU helps preserve normal bowel, urinary and sexual functions.
HIFU has been performed more than 30,000 times throughout the world since 2000. The therapy is currently undergoing evaluation in a multi-center U.S. Phase II/III clinical trial, but is not yet approved for non-investigational use.