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• W2037974906 abstract "You have accessJournal of UrologyProstate Cancer: Localized1 Apr 20131206 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 John Ward, Cary Robertson, Sebastien Crouzet, Stephen Brown, Viktor Berge, Christian Chaussy, Eduard Baco, A Paulesu, stefan Thuroff, Albert Gelet, and Andreas Blana John WardJohn Ward Houston, TX More articles by this author , Cary RobertsonCary Robertson Durham, NC More articles by this author , Sebastien CrouzetSebastien Crouzet Lyon, France More articles by this author , Stephen BrownStephen Brown Stockport, United Kingdom More articles by this author , Viktor BergeViktor Berge Oslo, Norway More articles by this author , Christian ChaussyChristian Chaussy Regensburg, Germany More articles by this author , Eduard BacoEduard Baco Oslo, Norway More articles by this author , A PaulesuA Paulesu Como, Italy More articles by this author , stefan Thuroffstefan Thuroff Munich, Germany More articles by this author , Albert GeletAlbert Gelet Lyon, France More articles by this author , and Andreas BlanaAndreas Blana Fuerth, Germany More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2560AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Ablatherm® HIFU is used as primary treatment for prostate cancer in Europe since 1993 and is currently under investigation in the U.S. under an FDA granted Investigational Device Exemption. The objective of this study is to report the biochemical and biopsy outcomes along with the morbidity evaluation of a population of low risk localized prostate cancer patients who meet the the FDA trial inclusion criteria. METHODS The @-Registry is a secured on-line database which collects de-identified clinical and technical information for patients undergoing HIFU treatment. The patient's selection criteria for this study were: low risk prostate cancer patients (cT1 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 according to the Phoenix definition (PSA nadir+2). Need for salvage treatment and biopsy data were also analyzed. The morbidity data were evaluated. RESULTS A total of 358 consecutive patients from 12 European HIFU centers met the inclusion criteria. The average age was 69.7 ± 6.4 years. Pre treatment PSA was 5.8 ± 2.4 ng/ml, the median Gleason sum was 6, 65.9% and 34.1% of patients were cT1and cT2a, respectively. Patients were followed for 6.6 ± 3.1 years (range: 0.6 to 18 years). Median PSA nadir was 0.09 ng/mL 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 were evaluated for all the 358 patients. Grade I, II and III stress incontinence was observed in 12.3%, 4.5% and 1.7% of the population, respectively. The bladder outlet obstruction rate was 20.7% (considering retention, stenosis and necrosis). No urethro-rectal fistula was observed. CONCLUSIONS HIFU provides good disease control with only 8.7% of patients receiving salvage treatment after HIFU through a follow-up period extending 18-years. HIFU therapy achieves good biochemical control at 10 years of follow-up for low risk cancer patients and negative biopsy rates are high. HIFU has low morbidity, especially with the lack of any serious morbidity (specifically fistulas). Bladder outlet obstruction has been the most bothersome adverse event. Ablatherm® HIFU treatment appears as a valuable and safe therapy for long term low risk prostate cancer treatment. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e494 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Ward Houston, TX More articles by this author Cary Robertson Durham, NC More articles by this author Sebastien Crouzet Lyon, France More articles by this author Stephen Brown Stockport, United Kingdom More articles by this author Viktor Berge Oslo, Norway More articles by this author Christian Chaussy Regensburg, Germany More articles by this author Eduard Baco Oslo, Norway More articles by this author A Paulesu Como, Italy More articles by this author stefan Thuroff Munich, Germany More articles by this author Albert Gelet Lyon, France More articles by this author Andreas Blana Fuerth, Germany More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ..." @default.
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• W2037974906 title "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" @default.
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