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

This study has been withdrawn prior to enrollment.
(Sponsor withdrew request to conduct study)
Sponsor:
Information provided by:
USHIFU, LLC
ClinicalTrials.gov Identifier:
NCT00537849
First received: September 27, 2007
Last updated: September 28, 2009
Last verified: April 2008
  Purpose

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.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by USHIFU, LLC:

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

Study Start Date: December 2007
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537849

Locations
Canada
The University of British Columbia
Vancouver, Canada, V5Z 1M9
Sponsors and Collaborators
USHIFU, LLC
Investigators
Principal Investigator: Alan I So, MD The Prostate Centre at Vancouver General Hospital
  More Information

No publications provided

Responsible Party: Andrew Green, VP Scientific Affairs, USHIFU
ClinicalTrials.gov Identifier: NCT00537849     History of Changes
Other Study ID Numbers: HIFU-PC-002
Study First Received: September 27, 2007
Last Updated: September 28, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 16, 2014