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High Intensity Focused Ultrasound for Primary Treatment of Localized Prostate Cancer: Early Experience with the EDAP Ablatherm HIFU® Device

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Douglas O Chinn MD, Arcadia, CA, Andreas Blana MD*, Fuerth, Germany, Wolfgang Wieland MD*, and Roman Ganzer MD*, Regensburg, Germany
(Presentation to be made by Dr. Douglas Chinn)
Purpose: The role of high intensity focused ultrasound (HIFU) in the treatment of prostate cancer has increased world-wide. Furthermore, this April, HIFU was added to the EAU guidelines as a treatment option, and France has instituted coverage for HIFU. Although long term outcome data on the use of the Ablatherm HIFU Device has been recently published, the data on Americans treated is still lacking. The purpose of this abstract is to present our technique and early experience in treating these patients.
Materials and Methods: From February 2007 through April 2014, 39 patients with biopsy proven T2a-T3b, Gleason scores 6-9 primary prostate cancer were treated with the Ablatherm HIFU® (EDAP TMS), either with total, subtotal or focal gland ablation (the latter 2 for potency sparing) in Germany by the same physicians (Blana & Chinn). 23 patients had potency sparing HIFU. All but 1 patient (prior simple open prostatectomy) had a transurethral resection of the prostate (TURP) performed prior to HIFU. All patients had TURP during the same anesthesia as HIFU. Patients had PSA measurements at 3 and 6 months, and biannually, thereafter. The first 11 patients routinely had biopsies done at 6 months. For all patients, a PSA > 0.5ng/ml after 6 months was indication for biopsy. Treatment failure was defined as it is for the Ablatherm® FDA clinical trial which is a composite definition of failure to achieve a nadir < 0.5ng/ml in the first 3 months OR PSA progression according to the ASTRO (3 rises) definition OR a positive biopsy.
Results: 9 failures including 2 repeat HIFU patients. Rising PSA’s >0.5 triggered biopsies, which in all but one patient were positive. The average follow-up was 39.8 months (range: 6-84). The mean PSA nadir for all patients was 0.466ng/ml (std. dev. 0.51). The mean PSA for patients who did not fail versus those who did fail, were 0.231ng/ml and 1.170ng/ml respectively. The overall success rate was 77% (30/39). With stratification by low, medium and high risk groups the success rates were 90% (9/10), 75% (6/8), and 71% (15/21), respectively.
Conclusions: Although the cohort is small and follow up is short, the early experience with Ablatherm HIFU® is encouraging for total gland ablation in the treatment of localized primary prostate cancer. Furthermore, in carefully selected cases, nerve sparing HIFU, utilizing subtotal gland ablation appears to be quite successful in the low risk patients. Further studies are required to validate these early and preliminary conclusions