Fusion Guided Focal Laser Ablation of Prostate Cancer

Enrolling by invitation · Not applicable

Conditions studied: Prostate Cancer, Prostate Neoplasms

In brief

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. ...

Key facts

Study ID

NCT02759744

Run by

National Institutes of Health Clinical Center (CC)

People needed

30

Starts

2017-10-13

Expected to finish

2027-01-21

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Patient unable to commit to follow-up
• Acute urinary tract infection
• Patients with uncontrolled coagulopathies
• Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes
• A serious acute or chronic illness that is determined by the PI to place the patient at unreasonable risk for anesthesia and the procedure.
• Inability to undergo a contrast enhanced MRI per American College of Radiology and the Clinical Center, Department of Radiology guidelines.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the Principal Investigator, would limit compliance with study requirements.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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