Prostate CancerNCT02759744
Fusion Guided Focal Laser Ablation of Prostate Cancer
A study testing ultrasound image-guided ablation device in people with Prostate Cancer and Prostate Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasms
- What is being tested?
- ultrasound image-guided ablation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2017to 31 Jul 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer
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).
Read more
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.
Read the detailed description
Background:
- Pilot study to evaluate the feasibility of real time ultrasound imaging to guide focal thermal ablation of low to intermediate 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 (data from this study was published in Diagnostic and Interventional Radiology). This data are 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 Tranberg CLS Thermal Therapy System and laser are 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 3000 patients, > 40,000 biopsies over the past 18 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 risk 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 >= 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
- Conditions
- Prostate Cancer, Prostate Neoplasms
- Being tested
- ultrasound image-guided ablation device
- Keywords
- Thermal Ablation, Localized Prostate Cancer, Medtronic-Visualase, Thermal Damage, PSA Levels
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound image-guided ablation deviceDevice
ultrasound image-guided focal ablation - may be either laser ablation or cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ultrasound image-guided focal ablation Receives: Device: ultrasound image-guided ablation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Assessment of thermal damage outside of intended treatment areas as measured by post contrast MRI, and the frequency of other adverse events and complications.
Measured: duration of protocol
Secondary outcomes (2)
To determine changes in imaging and biopsy characteristics after thermal ablation of prostate cancer.
Measured: 3 years after treatment completed
To analyze circulating tumor markers and functional markers in individuals with prostate cancer after receiving treatment over time
Measured: 2 weeks after the ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start13 Oct 2017
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter A Pinto, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759744
- Sponsor's protocol ID
- 160098
- Other IDs
- 16-CC-0098
- Status last verified
- 5 Oct 2026
- First submitted
- 22 Apr 2016
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esengur OT, Gelikman DG, Law YM, Yilmaz EC, Harmon SA, Merino MJ, Gurram S, Choyke PL, Wood BJ, Pinto PA, Turkbey B. Comparison of Transatlantic Recommendations for Prostate Gland Evaluation with MRI after Focal Therapy (TARGET) and Prostate Imaging after Focal Ablation (PI-FAB) for Detecting Recurrent Prostate Cancer at Prostate MRI. Acad Radiol. 2025 Feb;32(2):855-863. doi: 10.1016/j.acra.2024.09.051. Epub 2024 Oct 19.
PubMed 39426916