Fusion Guided Focal Laser Ablation of Prostate Cancer

Background:

- Pilot study to evaluate the feasibility of real time ultrasound imaging to guide focal
thermal ablation of low risk focal prostate tumors

- Prostate cancer is relatively slow growing, with doubling times for local tumors
estimated at 2 to 4 years.

- Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy
have pathologic features in the radical prostatectomy

specimen consistent with an insignificant or "indolent" cancer that poses little threat to
life or health.

- An NIH/NCI protocol #11-C-0158 titled MR Image guided focal laser ablation therapy of
prostate cancer has treated 15 patients without major complication over the past 5
years. Out of 15 patients, 3 have had evidence of disease recurrence. This data is being
prepared for publication (verbal communication with Peter Pinto, MD, principal
investigator); however, it requires a very long and resource-intensive MRI imaging,
which may be a barrier to broad translation to the community setting. Specialized custom
and expensive MRI-compatible equipment is also required. Focal laser ablation for
prostate cancer using the Medtronic-Visualase laser is FDA cleared.

- Focal thermal ablation such as laser ablation or cryosurgery are standard of care
therapies for prostate cancer, with cancer control comparable to that of external beam
radiotherapy and brachytherapy.

- NIH / NCI clinical trials have performed MRI + ultrasound (US) fusion biopsy in nearly
1500 patients, greater than 30,000 biopsies over the past 12 years.

- We propose to perform ultrasound (US) guided focal thermal ablation with fusion
visualization and co-display of pre-acquired MRI during the treatment of patients

Objectives:

- To determine the feasibility of treating biopsy-confirmed US-targetable and/or
MR-visible,low to intermediate grade prostate tumor(s) using ultrasound (US) image-guided
focal interstitial thermal ablation.

Eligibility:

- Patients must have organ confined, biopsy-confirmed, low or intermediate risk prostate
cancer that is either US-targetable or MR visible or both.

- Men greater than or equal to 18 years of age.

Design:

- Pilot study, testing feasibility of ultrasound-guided thermal ablation of focal prostate
cancer.

- A total of 30 patients will be enrolled to yield 20 evaluable patients.

- 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.