Fusion Guided Focal Laser Ablation of Prostate Cancer

Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer; Prostate Neoplasms
• Intervention / Treatment: Device: ultrasound image-guided ablation device

Detailed Description

Background:

• Pilot study to evaluate the feasibility of real time ultrasound imaging to guide focal thermal ablation of low to intermediate 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 (data from this study was published in Diagnostic and Interventional Radiology). This data are 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 Tranberg CLS Thermal Therapy System and laser are 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 3000 patients, > 40,000 biopsies over the past 18 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 risk 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 >= 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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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.

EXCLUSION CRITERIA:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; ultrasound image-guided focal ablation	Device: ultrasound image-guided ablation device; ultrasound image-guided focal ablation - may be either laser ablation or cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the feasibility of treating biopsy-confirmed and MR-visible, low-grade prostate tumor(s) using ultrasound (US) image-guided focal interstitial thermal ablation	Assessment of thermal damage outside of intended treatment areas as measured by post contrast MRI, and the frequency of other adverse events and complications.	duration of protocol

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine changes in imaging and biopsy characteristics after thermal ablation of prostate cancer.	3 years after treatment completed
To analyze circulating tumor markers and functional markers in individuals with prostate cancer after receiving treatment over time	2 weeks after the ablation.

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Peter A Pinto, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): January 21, 2027

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimated): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 17, 2026

More Information

Terms related to this study

• Keywords: Thermal Ablation; Localized Prostate Cancer; Medtronic-Visualase; Thermal Damage; PSA Levels
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 160098; 16-CC-0098

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No