Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00318240
First received: April 24, 2006
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

This is a feasibility study to determine safety and the ability of HIFU (High Intensity Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local recurrence of prostate cancer following radiation treatment.


Condition Intervention
Prostate Cancer
Device: High Intensity Focused Ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Destruction of prostate cancer tissue. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Safety of repeating procedure in patients who do not respond adequately. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2006
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High Intensity Focused
Device: High Intensity Focused Ultrasound
Treatment of Radiation failure in Prostate Cancer
Other Name: HIFU

Detailed Description:

This is a feasibility study to determine the safety and the ability of HIFU (High Intensity Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local recurrence of prostate cancer following radiation treatment. All participants will receive treatment with HIFU and be monitored closely for recurrence of disease (if any),quality of life and adverse events.

  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 recurrent prostate cancer (clinical Stages T1 and T2 only) who have been treated with external beam radiation therapy or brachytherapy and subsequently has biopsy-proven local recurrence.

    • Age > 40 years through <80 years.
    • Anesthesia Surgical Assignment (ASA) categories I, II or III only.
    • Negative radionuclide bone scan within 3 months prior to HIFU treatment to rule out the possibility of metastases.
    • PSA levels >0.5ng/ml and <10ng/ml.
    • Pre-radiation Gleason score < 8
    • Clearly imageable prostate on TRUS
    • Written informed consent.

Exclusion Criteria:

  • · T3 or T4 prostate cancer.

    • Age <40 years. or >80 years.
    • ASA of IV and higher.
    • Gleason score>8.
    • PSA <0.5ng/ml or >10ng/ml.
    • Prostate size > 40 grams as determined by transrectal ultrasound
    • Large calcification in the area to be treated (>5mm).
    • Bleeding disorder as determined by abnormal prothrombin time (INR)and partial thromboplastin time (PTT).
    • Patient on Coumadin or any other anticoagulant, unless their anticoagulation can 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 prostatic tissue adequately on transrectal ultrasound imaging.
    • Currently on hormonal therapy for prostate cancer (patients can be enrolled if they come off hormone therapy for 3 months).
    • History of treatment for prostate cancer, other than brachytherapy or external beam radiation.
    • 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.
  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: NCT00318240

Contacts
Contact: Urology Research Office 519-685-8300 ext 58448

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4G5
Principal Investigator: Joseph Chin, MD, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Dr. Joseph Chin University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dr. Joseph L Chin, London Health Sciences Center/University of Western Ontario
ClinicalTrials.gov Identifier: NCT00318240     History of Changes
Other Study ID Numbers: R-05-877, 11936
Study First Received: April 24, 2006
Last Updated: February 10, 2009
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
High Intensity Focused Ultrasound
Men
Locally recurrent prostate cancer.

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 August 01, 2014