Fusion Guided Focal Laser Ablation of Prostate Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT02759744
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • ultrasound image-guided ablation device — DEVICE
    ultrasound image-guided focal ablation - may be either laser ablation or cryotherapy

Study Details

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 Dates

Start date
Oct 13, 2017
Status verified
Apr 2026
Primary completion
Jan 21, 2027
Completion
Jan 21, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: 1
    ultrasound image-guided focal ablation

Primary Outcome Measure

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 [ Time Frame: duration of protocol ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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