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Brief Title: Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
Official Title: Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
Study ID: NCT00295802
Brief Summary: The purpose of this study is to determine the substantial equivalence of the Ablatherm high intensity focused ultrasound (HIFU) as compared to cryotherapy for the treatment of low risk, localized prostate cancer.
Detailed Description: Primary hypothesis of this clinical investigation is that HIFU with the Ablatherm Integrated Imaging is non-inferior to minimally invasive cryosurgery as an effective treatment method for low risk, localized prostate cancer.
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Chinn & Chinn Urology Associates, Arcadia, California, United States
Univeristy of Colorado Hospital and Health Science Center, Aurora, Colorado, United States
Florida Foundation for Healthcare Research Inc, Ocala, Florida, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Brooklyn Urology Research Group, Brooklyn, New York, United States
Sloan-Kettering Institute, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Urolgoy Associates of North Texas, Arlington, Texas, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Virginia Urology Center, Richmond, Virginia, United States
Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, United States
Maple Leaf HIFU, Hamilton, Ontario, Canada
Name: Carey Robertson, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR