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

NCT ID: NCT00318240

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

High Intensity Focused

Group Type: EXPERIMENTAL

High Intensity Focused Ultrasound

Intervention Type: DEVICE

Treatment of Radiation failure in Prostate Cancer

Interventions

High Intensity Focused Ultrasound

Treatment of Radiation failure in Prostate Cancer

Intervention Type: DEVICE

Other Intervention Names

HIFU

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Joseph Chin

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

11936

Identifier Type: -

Identifier Source: secondary_id

R-05-877

Identifier Type: -

Identifier Source: org_study_id