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• W2966346695 abstract "e15194 Background: Prostate Cancer (PCa) HIFU (Ablatherm, EDAP-TMS, Lyon, France) is currently under investigation in the US. This study reports biochemical, biopsy and morbidity outcomes for a population of low risk localized PCa patients meeting ENLIGHT FDA trial inclusion criteria. These data were accrued from European HIFU centers using an online HIFU database (@-Registry) . Methods: The patient’s selection criteria for this study were: low risk prostate cancer patients (T1c to T2a, PSA<10ng/ml, Gleason≤6), with a prostate A-P diameter and volume of <25mm and <40cc, and no pre-treatment hormone therapy. Kaplan-Meier analysis was performed to determine biochemical survival with failure defined as the Phoenix definition (PSA nadir+2). Morbidity data, need for salvage treatment and biopsy data were analyzed. Results: From 12 European centers, 358 men met the inclusion criteria. The baseline mean age, PSA and median Gleason sum were 69.7±6.4 years, 5.8±2.4 ng/ml and 6, respectively. Stage was 65.9% T1c and 34.1% T2a. Patients were followed for 6.6±3.1 years (range: 0.6 to 18 years). Median PSA nadir was 0.09 which was reached 13.9±10.7 weeks after HIFU. The salvage treatment rate was 8.7%, and the negative biopsy rate was 90.2% Actuarial BDFS at 5 and 10 years was 87% and 73% respectively. The morbidity data identified GradeI, II and III stress incontinence in 12.3%, 4.5% and 1.7% of the population, respectively. The Bladder Outlet Obstruction rate was 20.7% (urinary retention, urethral stenosis ). Urethro-rectal fistula was not observed. Conclusions: HIFU achieved good biochemical control at 10 years of follow-up for low riskPCa patients and negative biopsy rates were high. HIFU demonstrated an acceptable morbidity, especially with the lack of any serious events(specifically fistula). Bladder Outlet Obstruction was the most bothersome adverse event. HIFU appears as a valuable and safe therapy for long term low risk PCa treatment." @default.
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• W2966346695 date "2012-05-20" @default.
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• W2966346695 title "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." @default.
• W2966346695 doi "https://doi.org/10.1200/jco.2012.30.15_suppl.e15194" @default.
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