- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318240
Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
August 25, 2017 updated by: Lawson Health Research Institute
Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
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.
Study Overview
Status
Completed
Conditions
Intervention / 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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 4G5
- London Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
High Intensity Focused
|
Treatment of Radiation failure in Prostate Cancer
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.
Time Frame: ongoing
|
ongoing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Destruction of prostate cancer tissue.
Time Frame: ongoing
|
ongoing
|
Safety of repeating procedure in patients who do not respond adequately.
Time Frame: ongoing
|
ongoing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Joseph Chin, Western University, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2006
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
April 24, 2006
First Submitted That Met QC Criteria
April 24, 2006
First Posted (Estimate)
April 26, 2006
Study Record Updates
Last Update Posted (Actual)
August 28, 2017
Last Update Submitted That Met QC Criteria
August 25, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-05-877
- 11936
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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