Fusion Guided Focal Laser Ablation of Prostate Cancer

NCT02759744 | Enrolling By Invitation

• 2 other identifiers: 16009816-CC-0098
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Neoplasms; Prostate Cancer

Keywords

Thermal Ablation; Localized Prostate Cancer; Medtronic-Visualase; Thermal Damage; PSA Levels

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (1)

1

EXPERIMENTAL

ultrasound image-guided focal ablation

Device: ultrasound image-guided ablation device

Interventions

ultrasound image-guided ablation device DEVICE

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

1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• creatinine clearance: \>=60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter A Pinto, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 3, 2016
• Study Start: October 13, 2017
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): January 21, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04-17

Locations

US (1)