Fusion Guided Focal Laser Ablation of Prostate Cancer

• ClinicalTrials.gov Identifier: NCT02759744
• Recruitment Status: Enrolling by invitation
• First Posted: May 3, 2016
• Last Update Posted: March 1, 2019
• Sponsor: National Institutes of Health Clinical Center (CC)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC)

Tracking Information

• First Submitted Date: April 22, 2016
• First Posted Date: May 3, 2016
• Last Update Posted Date: March 1, 2019
• Actual Study Start Date: October 13, 2017
• Estimated Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2018)

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 [ Time Frame: duration 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.

• Original Primary Outcome Measures (submitted: April 29, 2016): To determine the feasibility of ultrasound (US) image-guided focal laser ablation of biopsy-confirmed and MR-visible, low-grade prostate tumor(s). [ Time Frame: duration of protocol ]

Current Secondary Outcome Measures (submitted: May 26, 2017)

• To determine changes in imaging and biopsy characteristics after thermal ablation of localized prostate cancer. [ Time Frame: 3 years after treatment completed ]
• To analyze circulating tumor markers and functional markers inindividuals with prostate cancer after receiving treatment over time [ Time Frame: 2 weeks after the ablation ]

• Original Secondary Outcome Measures (submitted: April 29, 2016): To determine changes in imaging and biopsy characteristics after thermal ablation of localized prostate cancer. [ Time Frame: 3 years after treatment completed ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fusion Guided Focal Laser Ablation of Prostate Cancer
• Official Title: Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer

Brief Summary

Background:

Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less aggressive disease are limited. Researchers want to test a device that destroys cancerous tissue with laser energy. They want to see if using it with ultrasound is more comfortable than using it with magnetic resonance imaging (MRI).

Objectives:

To test a cooled laser applicator system to treat prostate cancer lesions. To see if ultrasound imaging is a practical and feasible treatment with laser ablation for focal prostate cancer treatment.

Eligibility:

Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.

Design:

Participants will be screened with standard cancer care tests. These can include physical exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures. Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the rectum.

Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be put in the bladder. Ultrasound will guide the laser applicator directly to the tumor.

The cooling catheter will be removed. A different catheter will be put in the urethra to keep the bladder emptied.

The next day, participants will have a physical exam and a PSA blood test.

Participants will have 6 follow-up visits over 3 years. At each visit, they will have a physical exam and lab tests. At some visits, they will also have an MRI or other scans and a prostate biopsy.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Prostate Cancer
• Prostate Neoplasms

Intervention

Device: ultrasound image-guided ablation device

ultrasound image-guided focal ablation - may be either laser ablation or cryotherapy

Study Arms

Experimental: 1

ultrasound image-guided focal laser ablation device

Intervention: Device: ultrasound image-guided ablation device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Actual Enrollment (submitted: February 22, 2019): 9
• Original Estimated Enrollment (submitted: April 29, 2016): 30
• Estimated Study Completion Date: January 1, 2021
• Estimated Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

• 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02759744
• Other Study ID Numbers: 160098; 16-CC-0098
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: National Institutes of Health Clinical Center (CC)
• Study Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bradford J Wood, M.D.; National Institutes of Health Clinical Center (CC)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: February 21, 2019