High Intensity Focused Ultrasound for Radiorecurrent Prostate Cancer: A North American Clinical Trial

No AccessJournal of UrologyAdult Urology1 Jan 2018High Intensity Focused Ultrasound for Radiorecurrent Prostate Cancer: A North American Clinical Trial Tonye A. Jones, Joseph Chin, David Mcleod, Jack Barkin, Allan Pantuck, and Leonard S. Marks Tonye A. JonesTonye A. Jones Department of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California More articles by this author , Joseph ChinJoseph Chin Division of Urology, London Health Sciences Center, Toronto, Ontario, Canada More articles by this author , David McleodDavid Mcleod Department of Surgery, Center for Prostate Cancer Disease Research, Uniformed Services University of the Health Sciences and Walter Reed National Medical Military Center, Bethesda, Maryland More articles by this author , Jack BarkinJack Barkin Can-Am HIFU, Toronto, Ontario, Canada More articles by this author , Allan PantuckAllan Pantuck Department of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California More articles by this author , and Leonard S. MarksLeonard S. Marks Department of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.06.078AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We determined the safety and efficacy of whole gland high intensity focused ultrasound in men with radiorecurrent prostate cancer. Materials and Methods: A total of 100 men with clinically localized recurrent prostate cancer at least 2 years after external beam radiation therapy underwent whole gland high intensity focused ultrasound in an open label trial from 2009 to 2012. Treatments were performed at 16 sites, including 14 in the United States and 2 in Canada. The primary end point was the combination of a prostate specific antigen nadir of 0.5 ng/ml or less and negative biopsy at 12 months. Validated questionnaires were administered to monitor changes in urinary and sexual function. Results: Of the 100 treated men, in whom mean age was 70 years (range 53 to 83), 78 completed the 12-month biopsy, which was negative in 63 (81%). Mean prostate specific antigen was 4.9 ng/ml (range 0.4 to 14) and the median Gleason score was 7. The 1-year end point of a prostate specific antigen nadir of 0.5 ng/ml or less plus negative biopsy was achieved in 50 men. During post-trial followup mean prostate specific antigen at 2 years was 1.1 ng/ml (range 0.1 to 17) in 33 patients. Adverse events developed in 91 men through 12 months, which were CTCAE grade 1 in 67, grade 2 in 80 and grade 3 in 20. Treatment related grade 3 adverse events included rectal fistulas in 5 men, which required surgery in 3, osteitis pubis in 3 and hematuria requiring intervention in 3. Treatment related grade 3 adverse events developed early in the trial and appeared related to operator experience. 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Volume 199Issue 1January 2018Page: 133-139Supplementary Materials Advertisement Copyright & Permissions© 2018 by American Urological Association Education and Research, Inc.Keywordsprostatic neoplasmshigh-intensity focusedlocalpostoperative complicationsultrasoundneoplasm recurrencesalvage therapytransrectalMetricsAuthor Information Tonye A. Jones Department of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California More articles by this author Joseph Chin Division of Urology, London Health Sciences Center, Toronto, Ontario, Canada More articles by this author David Mcleod Department of Surgery, Center for Prostate Cancer Disease Research, Uniformed Services University of the Health Sciences and Walter Reed National Medical Military Center, Bethesda, Maryland More articles by this author Jack Barkin Can-Am HIFU, Toronto, Ontario, Canada More articles by this author Allan Pantuck Department of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California More articles by this author Leonard S. Marks Department of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California More articles by this author Expand All Advertisement PDF downloadLoading ...