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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intensity Focused Ultrasound
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring High Intensity Focused Ultrasound, Men, Locally recurrent prostate cancer.

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

High Intensity Focused

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2006
Last Updated
August 25, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00318240
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (Actual)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
High Intensity Focused Ultrasound, Men, Locally recurrent prostate cancer.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
High Intensity Focused
Intervention Type
Device
Intervention Name(s)
High Intensity Focused Ultrasound
Other Intervention Name(s)
HIFU
Intervention Description
Treatment of Radiation failure in Prostate Cancer
Primary Outcome Measure Information:
Title
To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.
Time Frame
ongoing
Secondary Outcome Measure Information:
Title
Destruction of prostate cancer tissue.
Time Frame
ongoing
Title
Safety of repeating procedure in patients who do not respond adequately.
Time Frame
ongoing

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Joseph Chin
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada

12. IPD Sharing Statement

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

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