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Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)

40 Years
80 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)

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.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Dr. Joseph Chin

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Western Ontario, Canada


Canada: Health Canada

Study ID:




Start Date:

April 2006

Completion Date:

April 2009

Related Keywords:

  • Prostate Cancer
  • High Intensity Focused Ultrasound
  • Men
  • Locally recurrent prostate cancer.
  • Prostatic Neoplasms