Fusion Guided Focal Laser Ablation of Prostate Cancer

Official record

Identifier

NCT02759744

Recruiting locations

country

United States

Interventions studied

ultrasound image-guided ablation device

Lead sponsor

National Institutes of Health Clinical Center (CC)

Target enrolment

30 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Enrolling by invitation

First posted

May 3, 2016

Last updated on the registry

Aug 13, 2026

Age

18 Years – 100 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

* 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.

Indexed under

Prostate Cancer