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

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Device: Sonablate 500 (SB-500)	Phase IV

MedlinePlus related topics:

Cancer Prostate Cancer Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by USHIFU, LLC:

Primary Outcome Measures:

PSA level [ Time Frame: PSA level at 30 and 90 days post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2009

Intervention Details:

Sonablate 500 (SB-500)

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573586

Contacts


Contact: George Vrabec, MD		gvrabec@hotmail.com

Locations


Canada, British Columbia
	Abbotsford Regional Hospital Cancer Center	Not yet recruiting
	Abbotsford, British Columbia, Canada
	Principal Investigator: George Vrabec, MD

Sponsors and Collaborators

USHIFU, LLC

Investigators


Principal Investigator:	George Vrabec, MD	Abbotsford Regional Hospital Cancer Center

More Information

Responsible Party:	Principle Investigator ( George Vrabec, MD )
Study ID Numbers:	USHIFU-CABC-PC002
First Received:	December 12, 2007
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00573586
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	USHIFU, LLC
Information provided by:	USHIFU, LLC
ClinicalTrials.gov Identifier:	NCT00573586