Fusion Guided Focal Laser Ablation of Prostate Cancer

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Apr 29, 2016

Keywords

ClinConnect Summary

This is a pilot study at the NIH Clinical Center that’s testing whether ultrasound-guided focal thermal ablation (a cooled laser treatment) can safely destroy small, localized prostate cancers that are visible on MRI or targeted by ultrasound. It is a single-group feasibility trial, meaning all participants receive the same treatment, to see if this approach can be done reliably and with acceptable safety. About 30 men with organ-confined, low- to intermediate-risk prostate cancer may be eligible. Key eligibility includes having cancer that is MRI-visible or ultrasound-targetable, a recent MRI and prostate biopsy within about the last year, adequate overall health, and cancer that is at least 8 mm away from nearby critical areas. Men must be able to consent and follow the study plan; certain conditions (like active infections or bleeding risks, or inability to have MRI) would exclude participation.

What to expect if you enroll: you would undergo standard screening tests, and the procedure uses real-time ultrasound (often with MRI fusion) to guide the laser to the cancer while trying to limit damage to surrounding tissue. You may stay in the clinic about 1–2 days, with a cooling catheter in the bladder and a urethral catheter afterward to help empty the bladder. The day after treatment includes a physical exam and a PSA blood test. Participants have about six follow-up visits over 3 years, which may include physical exams, lab tests, MRI scans, and possibly a prostate biopsy. The study’s main goal is to see if this ultrasound-guided approach can be performed safely and effectively, with attention to any tissue damage outside the target area and any side effects, while also collecting imaging, biopsy, and blood-marker data over time.

Gender

MALE

Eligibility criteria

• * 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.