NCT02759744Enrolling by invitation

Fusion Guided Focal Laser Ablation of Prostate Cancer

Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Enrolling by invitation
Study type: Interventional
Enrollment: 30 (estimated)
First submitted: 22 Apr 2016
Start date: 13 Oct 2017
Primary completion date: 31 Jul 2029
Lead sponsor: National Institutes of Health Clinical Center (CC)
Diseases: Prostate cancer
NCT number: NCT02759744

What you commit to

Study type: Interventional
Planned participants: 30
From 13 Oct 2017 to the primary completion date, 31 Jul 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Acute urinary tract infection
A serious acute or chronic illness that is determined by the PI to place the patient at unreasonable risk for anesthesia and the procedure.
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.

Other

Patient unable to commit to follow-up
Patients with uncontrolled coagulopathies
Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes
Inability to undergo a contrast enhanced MRI per American College of Radiology and the Clinical Center, Department of Radiology guidelines.

Criteria the registry did not label

INCLUSION CRITERIA:
Enrollment open only to current NIH patients enrolled in 16-C-0010.
Patients
- Patients must have clinically localized, non-aggressive, favorable or unfavorable, low to intermediate risk prostate cancer as defined per current NCCN guidelines (i.e, including review and determination of pathology and tumor characteristics, Gleason Score, PSA levels, and other assessments as clinically appropriate).Organ confined clinical prostate cancer that is US-targetable and/ or visualized on MRI or by a semi-automated software tool
Prostate cancer diagnosed by transrectal or transperineal US-guided standard 12 core needle biopsy, MR image-guided needle biopsy, or MR/US fusion-guided needle biopsies or biopsies performed under semi-automated tools.
Targeted tumors must be considered a safe distance (\>= 8 mm) from the urethra, rectal wall, bladder wall or neurovascular bundle by the Principal Investigator.
Must have had a prostate MRI performed at the NIH within 12 months prior to enrollment.
Must have had a prostate biopsy performed at NIH within 12 months (+2 months) prior to enrollment.
Men \>18 years of age.
ECOG performance status \<=2.
Patients must have adequate organ and marrow function as defined below:
- leukocytes: \>=3,000/mcL
- absolute neutrophil count: \>=1,500/mcL
- platelets: \>=75,000/mcL
- creatinine: within normal institutional limits
- OR
- --creatinine clearance: \>=60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
Preoperative clearance by NIH Department of Anesthesia and Surgical Services
Ability of subject to understand and the willingness to sign a written informed consent document.
Subject understands that this is an experimental protocol and that there are available standard treatment options. These options would include but not be limited to: active surveillance, external beam radiation and brachytherapy, androgen deprivation therapy, or prostatectomy.

Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.