Back to results

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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Sonablate 500 (SB-500)

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Abbotsford Regional Hospital Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HIFU

Arm Description

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

Outcomes

Primary Outcome Measures

PSA level

Secondary Outcome Measures

Full Information

NCT ID

NCT00573586

First Posted

December 12, 2007

Last Updated

May 1, 2019

Sponsor

SonaCare Medical

1. Study Identification

Unique Protocol Identification Number

NCT00573586

Brief Title

Treatment of Localized Prostate Cancer With High Intensity Focused Ultrasound Using the Sonablate® 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

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SonaCare Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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

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

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIFU

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Sonablate 500 (SB-500)

Intervention Description

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

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

George Vrabec, MD

Phone

604-587-4628

gvrabec@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Susan Chunik

Phone

604-587-4628

susan.chunick@fraserhealth.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Vrabec, MD

Organizational Affiliation

Abbotsford Regional Hospital Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abbotsford Regional Hospital Cancer Center

City

Abbotsford

State/Province

British Columbia

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

George Vrabec, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs