- Four scientific sessions highlighting HIFU outcomes for treatment of prostate cancer
- One AUA accepted poster presentation highlighting Sonolith lithotripter and its exclusive ultrasound Visio Track ® localization system
- EDAP attending the FDA Public Workshop on prostate cancer clinical trial design issues
LYON, France, May 1, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced its participation at the American Urological Association (AUA) 2013 Annual Meeting, held in San Diego on May 4-8, 2013. EDAP will showcase its device portfolio at AUA booth #2845, and the Sonolith i-move will be available for live demonstrations. The Company's HIFU and lithotripsy data will be highlighted in five posters during the AUA scientific session.
EDAP plans to attend the FDA Public Workshop entitled "Clinical Trial Design Issues – Drug and Device Development for Localized Prostate Cancer" that will be held on Sunday, May 5. The workshop will focus on trial design issues related to the development of new therapies for localized prostate cancer including patient selection, comparators, and study endpoints.
Scientific Session HighlightsDate/Time: Monday, May 6, 1:00 pm Poster 1205: Age stratified outcomes after primary HIFU for organ localized prostate cancer in the series of 5206 patient s – This multinational study included 5206 patients from the @-Registry (the online Ablatherm Treatment database) and found similar negative biopsy rates, higher biochemical survivals and lower morbidity for men < 70 years. HIFU had already been recognized as a therapeutic option in patients over 70 years old with 10 years life expectancy and this study demonstrates positive results in a younger population. HIFU therefore appears as a valuable therapeutic option for prostate cancer control independent of age. Date/Time: Monday, May 6, 1:00 pm Poster 1206 - Biochemical survival and Morbidity of High Intensity Focused Ultrasound (HIFU) as a Primary Monotherapy for Low-Risk Localized Prostate Cancer: Outcomes from the @-Registry following the ENLIGHT Trial inclusion criteria The objective of this study was to report the biochemical and biopsy outcomes along with the morbidity of a population of low risk localized prostate cancer patients who meet the the FDA trial inclusion criteria. With a follow-up extending to 18 years, only 8.7% of patients received salvage treatment after HIFU. HIFU achieved good biochemical control at 10 years of follow-up for low risk cancer patients and negative biopsy rates were high. Ablatherm® HIFU treatment appears as a valuable and safe therapy for long term low risk prostate cancer treatment.