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
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|ClinicalTrials.gov Identifier: NCT00537849|
Recruitment Status : Withdrawn (Sponsor withdrew request to conduct study)
First Posted : October 1, 2007
Last Update Posted : September 29, 2009
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: Sonablate 500(SB-500)|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2007|
|Estimated Primary Completion Date :||March 2008|
|Estimated Study Completion Date :||March 2008|
- PSA level [ Time Frame: PSA level at 30 and 90 days post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537849
|The University of British Columbia|
|Vancouver, Canada, V5Z 1M9|
|Principal Investigator:||Alan I So, MD||The Prostate Centre at Vancouver General Hospital|