Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the Sonablate 500 (SB-500) System in Canada
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the Sonablate 500 (SB-500) System in Canada|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537849
|The University of British Columbia|
|Vancouver, Canada, V5Z 1M9|
|Principal Investigator:||Alan I So, MD||The Prostate Centre at Vancouver General Hospital|