Back to resultsInvestigational 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
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sonablate 500(SB-500)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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).
Sites / Locations
- The University of British Columbia
Outcomes
Primary Outcome Measures
PSA level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00537849
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor withdrew request to conduct study
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SonaCare Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Sonablate 500(SB-500)
Primary Outcome Measure Information:
Title
PSA level
Time Frame
PSA level at 30 and 90 days post treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan I So, MD
Organizational Affiliation
The Prostate Centre at Vancouver General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of British Columbia
City
Vancouver
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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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