Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Attainment achievement of prostate-specific antigen (PSA) nadir < 0.5 ng/ml and stability of PSA according to American Society for Therapeutic Radiology and Oncology (ASTRO) criteria through 24 month follow up without a positive biopsy
Carey Robertson, MD
Principal Investigator
Duke University
United States: Food and Drug Administration
G050103
NCT00295802
April 2006
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Virginia Urology Center | Richmond, Virginia 23230 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Duke University Medical Center | Durham, North Carolina 27710 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
Urology Associates of Central CA | Fresno, California 93720 |
The University of Texas M.D. Anderson Cancer Center | Houston, Texas |
Scott & White Hospital | Temple, Texas 76508 |
Chinn & Chinn Urology Associates | Arcadia, California 91006 |
Univeristy of Colorado Hospital and Health Science Center | Aurora, Colorado 80010 |
Florida Foundation for Healthcare Research Inc | Ocala, Florida 34474 |
Brooklyn Urology Research Group | Brooklyn, New York 11215 |
Sloan-Kettering Institute | New York, New York 10021 |
Triangle Urology | Pittsburgh, Pennsylvania 15212 |
Urolgoy Associates of North Texas | Arlington, Texas 76017 |
Medical College of Wisconsin, Inc. | Milwaukee, Wisconsin 53226 |