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Fusion Guided Focal Laser Ablation of Prostate Cancer

NCT02759744 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

ultrasound image-guided ablation device

ultrasound image-guided focal ablation - may be either laser ablation or cryotherapy

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Peter A Pinto, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2027-01-21
Completion
2027-01-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02759744 on ClinicalTrials.gov