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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

NCT00537849 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-04-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Sonablate 500(SB-500)

Sponsors & Collaborators

  • SonaCare Medical

    lead INDUSTRY

Principal Investigators

  • Alan I So, MD · The Prostate Centre at Vancouver General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537849 on ClinicalTrials.gov