NCT00573586

Treatment of Localized Prostate Cancer With High Intensity Focused Ultrasound Using the Sonablate® 500 System in Canada

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: SonaCare Medical · Industry
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an investigational study on the use of high intensity focused ultrasound (HIFU) in the management of localized prostate cancer (T1c/T2a) 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 patients, with minimal and acceptable adverse effects

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Sonablate 500 (SB-500)	Sonablate 500 (SB-500)

Timeline

• Start date: 2020-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2007-12-14
• Last updated: 2019-05-03

Locations

1 site across 1 country: Canada