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High Intensity Focused Ultrasound Clinical Trial

Holly Kelly, RN, Clinical Research Manager


The Department of Urology is participating in a high intensity focused ultrasound (HIFU) trial for the treatment of clinically localized prostate cancer. We are currently one of 12 locations in the United States and Canada and the only site in the Midwest participating in this study. Robert Donnell, MD, is the principal investigator for our site.

The device being utilized is the Ablatherm®, an integrated imaging system designed to target and deliver high intensity focused ultrasound energy to the prostate gland, resulting in thermal destruction of prostate tissue. The focused energy is delivered from an endorectal probe containing ultrasound treatment and imaging transducers. Treatment is expected to result in immediate thermal destruction of prostate tissue. This is performed under spinal or general anesthesia on an outpatient basis. Patients enrolled in the study have low risk prostate cancer. The study’s inclusion criteria included: clinical stage T1-T2a and prostate specific antigen (PSA) <10 ng/mL, Gleason score <6, AP diameter <25mm and prostate volume <40cc.

Although this is a pioneering study in the United States, approximately 5,000 patients, primarily in Europe, have thus far been treated with this device. In most cases, the HIFU procedure takes approximately one and one half to three hours. Published reports of patients treated with the Ablatherm HIFU device reveal encouraging treatment success rates based upon PSA follow up and histologic examination of post-treatment prostate biopsies. The desired endpoint of the current study we are participating in defines success as a PSA nadir <0.5ng/ml and stability of PSA through 24 months without a positive post-treatment biopsy. The most prevalent side effects noted in European literature have been ejaculatory problems, bladder outlet obstruction, impotence and dysuria.


  1. M Colombel, A Gelet, J.Y. Chapelon, R. Bouvier, O. Rouviere, J.M. Dubernard. Transrectal Focused Ultrasound and Localized Prostate Cancer: May the Nadir PSA Predict the Treatment Success. Abstract from European Association of Urology, Madrid, 2003.
  2. G. Conti, A Paulesu, R Nespoli, V Lancini, G Comeri, High Intensity Focused Ultrasound (HIFU) for the Treatment of Localized Prostate Cancer. Abstract from European Association of Urology, Madrid, 2003.
  3. S Thuroff, C Chaussy, G Vallancien, W Wieland, HJ Kiel, A Le Duc, F Desgrandchamps, J J.M.C.H. De La Rosette, A Gelet. High-Intensity Focused Ultrasound and Localized Prostate Cancer: Efficacy Results from the European Multicentric Study. Journal of Endourology. 2003; 17: 673-677.
  4. S Thuroff, C Chaussy. High-Intensity Focused Ultrasound: Complications and Adverse Events. Molecular Urol. 2000; 4:183-187.
  5. A. Blana, B. Walter, S. Rogenhofer, W. Wieland. High-Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer: 5-Year
    Experience. Urology. 2004; 63: 297-300.
© 2014 Medical College of Wisconsin
Page Updated 08/12/2014