NCT02759744
Fusion Guided Focal Laser Ablation of Prostate Cancer
Enrolling by Invitation
NAAges 18+InterventionalDevice feasibilityNational Institutes of Health Clinical Center (CC)Government-funded
~30 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:ultrasound image-guided ablation device
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over duration of protocol
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Peter A Pinto, M.D. · PRINCIPAL_INVESTIGATOR · National Institutes of Health Clinical Center (CC)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Enrollment open only to current NIH patients enrolled in 16-C-0010.
Patients
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.
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
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.
What this trial measures
- To determine the feasibility of treating biopsy-confirmed and MR-visible, low-grade prostate tumor(s) using ultrasound (US) image-guided focal interstitial thermal ablationduration of protocol
Assessment of thermal damage outside of intended treatment areas as measured by post contrast MRI, and the frequency of other adverse events and complications.