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

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ClinicalTrials.gov Identifier: NCT00573586
Recruitment Status : Unknown
Verified March 2010 by SonaCare Medical.
Recruitment status was:  Not yet recruiting
First Posted : December 14, 2007
Last Update Posted : March 8, 2010
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Sonablate 500 (SB-500) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Sonablate 500 (SB-500)
    Sonablate 500 (SB-500)

Outcome Measures

Primary Outcome Measures :
  1. PSA level [ Time Frame: PSA level at 30 and 90 days post treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
SonaCare Medical
Investigators
Principal Investigator: George Vrabec, MD Abbotsford Regional Hospital Cancer Center
More Information

Responsible Party: George Vrabec, MD, Principle Investigator
ClinicalTrials.gov Identifier: NCT00573586     History of Changes
Other Study ID Numbers: USHIFU-CABC-PC002
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: March 8, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases