Fusion Guided Focal Laser Ablation of Prostate Cancer
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ClinicalTrials.gov Identifier: NCT02759744 |
Recruitment Status :
Enrolling by invitation
First Posted : May 3, 2016
Last Update Posted : February 21, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | April 22, 2016 | ||||
First Posted Date ICMJE | May 3, 2016 | ||||
Last Update Posted Date | February 21, 2021 | ||||
Actual Study Start Date ICMJE | October 13, 2017 | ||||
Estimated Primary Completion Date | January 21, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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 ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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 ICMJE | Fusion Guided Focal Laser Ablation of Prostate Cancer | ||||
Official Title ICMJE | 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. |
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Detailed Description | Background:
specimen consistent with an insignificant or "indolent" cancer that poses little threat to life or health.
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:
Design:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: ultrasound image-guided ablation device
ultrasound image-guided focal ablation - may be either laser ablation or cryotherapy
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Study Arms ICMJE | Experimental: 1
ultrasound image-guided focal laser ablation device
Intervention: Device: ultrasound image-guided ablation device
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Actual Enrollment ICMJE |
14 | ||||
Original Estimated Enrollment ICMJE |
30 | ||||
Estimated Study Completion Date ICMJE | January 1, 2026 | ||||
Estimated Primary Completion Date | January 21, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
radiologists.
OR
or prostatectomy. EXCLUSION CRITERIA:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02759744 | ||||
Other Study ID Numbers ICMJE | 160098 16-CC-0098 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | National Institutes of Health Clinical Center (CC) | ||||
Study Sponsor ICMJE | National Institutes of Health Clinical Center (CC) | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | February 13, 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |