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

Prostate Cancer Clinical Trial

Official title:

Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318240
• Other study ID #: R-05-877
• Secondary ID: 11936
• Status: Completed
• Phase: N/A
• First received: April 24, 2006
• Last updated: August 25, 2017
• Start date: April 2006
• Est. completion date: April 2009

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• High Intensity Focused Ultrasound
Treatment of Radiation failure in Prostate Cancer

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.		ongoing
Secondary	Destruction of prostate cancer tissue.		ongoing
Secondary	Safety of repeating procedure in patients who do not respond adequately.		ongoing