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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: High Intensity Focused Ultrasound

• Registration Number: NCT00318240
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-24
• Study First Submitted QC: 2006-04-24
• Study First Posted: 2006-04-26
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	High Intensity Focused Ultrasound	High Intensity Focused

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Destruction of prostate cancer tissue.	ongoing
Safety of repeating procedure in patients who do not respond adequately.	ongoing

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada