Fusion Guided Focal Laser Ablation of Prostate Cancer

This is an interventional device feasibility trial for Prostate Cancer focused on measuring Thermal Ablation, Localized Prostate Cancer, Medtronic-Visualase, Thermal Damage, PSA Levels Read More

• INCLUSION CRITERIA:
• Enrollment open only to current NIH patients enrolled in 16-C-0010.
• Patients must have clinically localized, non-aggressive, low to favorable 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 hat is US-targetable and/ or visualized on MRI-- T1c Tumor identified by needle biopsy (e.g., because of elevated PSA)
• Prostate cancer diagnosed by transrectal or transperineal US guided standard 12 core needle biopsy or MR image guided needle biopsy, or MR / US fusion guided needle biopsies.

radiologists.

• Targeted tumors must be considered a safe distance from the urethra, rectal 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 greater than or equal to 18 years of age.
• ECOG performance status less than or equal to 2

• Patients must have adequate organ and marrow function as defined below:

  • leukocytes greater than or equal to 3,000/mcL
  • absolute neutrophil count greater than or equal to 1,500/mcL
  • platelets greater than 75,000/mcL
  • creatinine within normal institutional limits

OR

• creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 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.