Status:
COMPLETED
Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
Phase:
NA
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 pros...
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 ...
Eligibility Criteria
Inclusion
- · 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
- · 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00318240
Start Date
April 1 2006
End Date
April 1 2009
Last Update
August 28 2017
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5