Fusion Guided Focal Laser Ablation of Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer

Status Suspended

Clinical Trial Summary

Background:

Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less aggressive disease are limited. Researchers want to test a device that destroys cancerous tissue with laser energy. They want to see if using it with ultrasound is more comfortable than using it with magnetic resonance imaging (MRI).

Objectives:

To test a cooled laser applicator system to treat prostate cancer lesions. To see if ultrasound imaging is a practical and feasible treatment with laser ablation for focal prostate cancer treatment.

Eligibility:

Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.

Design:

Participants will be screened with standard cancer care tests. These can include physical exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures. Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the rectum.

Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be put in the bladder. Ultrasound will guide the laser applicator directly to the tumor.

The cooling catheter will be removed. A different catheter will be put in the urethra to keep the bladder emptied.

The next day, participants will have a physical exam and a PSA blood test.

Participants will have 6 follow-up visits over 3 years. At each visit, they will have a physical exam and lab tests. At some visits, they will also have an MRI or other scans and a prostate biopsy.

Clinical Trial Description

Background:

• Pilot study to evaluate the feasibility of real time ultrasound imaging to guide focal thermal ablation of low risk focal prostate tumors

• Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.

• Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy

specimen consistent with an insignificant or "indolent" cancer that poses little threat to life or health.

• An NIH/NCI protocol #11-C-0158 titled MR Image guided focal laser ablation therapy of prostate cancer has treated 15 patients without major complication over the past 5 years. Out of 15 patients, 3 have had evidence of disease recurrence. This data is being prepared for publication (verbal communication with Peter Pinto, MD, principal investigator); however, it requires a very long and resource-intensive MRI imaging, which may be a barrier to broad translation to the community setting. Specialized custom and expensive MRI-compatible equipment is also required. Focal laser ablation for prostate cancer using the Medtronic-Visualase laser is FDA cleared.

• Focal thermal ablation such as laser ablation or cryosurgery are standard of care therapies for prostate cancer, with cancer control comparable to that of external beam radiotherapy and brachytherapy.

• NIH / NCI clinical trials have performed MRI + ultrasound (US) fusion biopsy in nearly 1500 patients, greater than 30,000 biopsies over the past 12 years.

• We propose to perform ultrasound (US) guided focal thermal ablation with fusion visualization and co-display of pre-acquired MRI during the treatment of patients

Objectives:

• To determine the feasibility of treating biopsy-confirmed US-targetable and/or MR-visible,low to intermediate grade prostate tumor(s) using ultrasound (US) image-guided focal interstitial thermal ablation.

Eligibility:

• Patients must have organ confined, biopsy-confirmed, low or intermediate risk prostate cancer that is either US-targetable or MR visible or both.

• Men greater than or equal to 18 years of age.

Design:

• Pilot study, testing feasibility of ultrasound-guided thermal ablation of focal prostate cancer.

• A total of 30 patients will be enrolled to yield 20 evaluable patients. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasms
• Prostatic Neoplasms

• NCT number: NCT02759744
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Suspended
• Phase: N/A
• Start date: October 13, 2017
• Completion date: January 21, 2026