Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
High Intensity Focused Ultrasound, Men, Locally recurrent prostate cancer.
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: High Intensity Focused Ultrasound
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 40 Years
Gender: Male
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.
Location
London Health Sciences Centre
London, Ontario, Canada
Status: Recruiting
Start Date
April 2006
Completion Date
April 2009
Sponsors
Lawson Health Research Institute
Source
Lawson Health Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page