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CompletedNCT00318240Updated Aug 28, 2017

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

An interventional study of High Intensity Focused Ultrasound in Prostate Cancer, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-28.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
40 Years to 80 Years
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • High Intensity Focused Ultrasound
  • Men
  • Locally recurrent prostate cancer.
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 40 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    1

    High Intensity Focused

    Device: High Intensity Focused Ultrasound

Interventions

  • DeviceHigh Intensity Focused Ultrasound

    Treatment of Radiation failure in Prostate Cancer

    Also known as: HIFU

06

What researchers measure

Primary outcomes

  1. To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.

    Time frame: ongoing

Secondary outcomes

  1. Destruction of prostate cancer tissue.

    Time frame: ongoing

  2. Safety of repeating procedure in patients who do not respond adequately.

    Time frame: ongoing

07

Study locations

1 site
  • London Health Sciences Centre
    London, Ontario N6A 4G5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00318240
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Responsible party
Sponsor
First posted
Apr 26, 2006
Start date
Apr 2006
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Aug 28, 2017

Study contacts

Dr. Joseph Chin
principal investigator · Western University, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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