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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00573586
• Other study ID #: USHIFU-CABC-PC002
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: December 2020

Study information

• Verified date: May 2019
• Source: SonaCare Medical
• Contact: George Vrabec, MD
• Phone: 604-587-4628
• Email: gvrabec[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Sonablate 500 (SB-500)
Sonablate 500 (SB-500)

Locations

Country	Name	City	State
Canada	Abbotsford Regional Hospital Cancer Center	Abbotsford	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
SonaCare Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA level		PSA level at 30 and 90 days post treatment