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

April 8, 2019 updated by: SonaCare Medical

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Vancouver, Canada, V5Z 1M9
        • The University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patients with an initial presentation of organ confined prostate cancer;(clinical stages T1c and T2a only)
  • Age 40 yrs. and older up to and including age 80 yrs.;
  • Anesthesia SUrgical Assignment (ASA) categories I, II or III only;
  • PSA levels equal tyo or less than 10ng/ml;
  • Pre-HIFU Gleason score equal to or less than 7;
  • Clearly imageable prostate on TRUS;
  • Prostate total volume less than 40cc with an AP height less than or equal to 4.2cm. (If volume is greater than 40cc or height greater than 4.2 cm, one 3 monthly shot of an LHRH analogue may be provided, followed by re-imaging of the prostate to document total volume below 40cc).

Exclusion Criteria:

  • Large calcification in the area to be treated (>5mm);
  • Bleeding disorder as determined by abnormal prothrombin time (INR) and partial thromboplastin time (PTT);
  • Pt. on Coumadin or any other anticoagulent, unless their anticoagulation an be temporarily reversed or stopped;
  • Urinary Tract infection unless treated satisfactorily by antibiotics and documented by a sterile urine culture;
  • Interest in future fertility;
  • History of allergy to latex;
  • Inability to visualize the prostate tissue adequately on transrectal ultrasound imaging;
  • History of treatment for prostate cancer (except for one LHRH analogue "shrinkage shot");
  • History of TURP, thermotherapy or urethral stent;
  • History of any major rectal surgery;
  • History of inflammatory bowel disease;
  • History of urinary bladder neck contracture;
  • History of any other malignancy other than skin cancer. Patients that have had a previous malignancy and no recurrence of that malignancy within the past 5 years will be allowed; (superficial bladder cancer is OK of clear for 2 years)
  • Inability to be placed in lithotomy position;
  • Prior long term hormonal therapy for prostate cancer (including bilateral orchiectomy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PSA level
Time Frame: PSA level at 30 and 90 days post treatment
PSA level at 30 and 90 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SonaCare Medical

Investigators

  • Principal Investigator: Alan I So, MD, The Prostate Centre at Vancouver General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

March 1, 2008

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 30, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIFU-PC-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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