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An investigational study on the use of HIFU in the management of localized prostate cancer as a primary non-comparative study High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that uses intersecting, precision focused ultrasound waves to raise the temperature of the target to )80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The tissue targeting is highly precise, minimizing collateral damage. The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed with localized T1c/T2a prostate cancer, with minimal morbidity. The specific hypothesis is that the Sonablate has the ability to: * COmpletely destroy prostate cancer tissue, without causing damage to the intervening tissue, with a drop in PSA levels to \<0.5ng/ml. * Result in negative biopsies for evidence of viable malignant cells after the treatment(12 months if Nadir is not reached or PSA rises from Nadir) * Safely treat localized prostate cancer pts., with minimal and acceptable adverse effects.
Age
40 - 80 years
Sex
MALE
Healthy Volunteers
No
The University of British Columbia
Vancouver, Canada
Start Date
December 1, 2007
Primary Completion Date
March 1, 2008
Completion Date
March 1, 2008
Last Updated
April 10, 2019
Sonablate 500(SB-500)
DEVICE
Lead Sponsor
SonaCare Medical
NCT06842498
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT04550494