Clinical trial NCT00318240: Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
Official title: Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: High Intensity Focused Ultrasound
Men
Locally recurrent prostate cancer.
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.
timeFrame: ongoing
Secondary outcomes:
measure: Destruction of prostate cancer tissue.
timeFrame: ongoing
measure: Safety of repeating procedure in patients who do not respond adequately.
timeFrame: ongoing
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Dr. Joseph Chin
role: PRINCIPAL_INVESTIGATOR
References: