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.
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