Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Lawson Health Research Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Lawson Health Research Institute
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00318240
First received: April 24, 2006
Last updated: February 10, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Device: High Intensity Focused Ultrasound |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU) |
Resource links provided by NLM:
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures:
- To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Destruction of prostate cancer tissue. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
- Safety of repeating procedure in patients who do not respond adequately. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
High Intensity Focused
|
Device: High Intensity Focused Ultrasound
Treatment of Radiation failure in Prostate Cancer
Other Name: HIFU
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318240
Contacts
| Contact: Urology Research Office | 519-685-8300 ext 58448 |
Locations
| Canada, Ontario | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4G5 | |
| Principal Investigator: Joseph Chin, MD, FRCSC | |
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
| Principal Investigator: | Dr. Joseph Chin | University of Western Ontario, Canada |
More Information
No publications provided
| Responsible Party: | Dr. Joseph L Chin, London Health Sciences Center/University of Western Ontario |
| ClinicalTrials.gov Identifier: | NCT00318240 History of Changes |
| Other Study ID Numbers: | R-05-877, 11936 |
| Study First Received: | April 24, 2006 |
| Last Updated: | February 10, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Lawson Health Research Institute:
|
High Intensity Focused Ultrasound Men Locally recurrent prostate cancer. |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013