Clinical trial · Interventional
Fusion Guided Focal Laser Ablation of Prostate Cancer
Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultrasound image-guided ablation device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- ultrasound image-guided focal ablation
- interventionNames
- Device: ultrasound image-guided ablation device
Primary outcomes (1)
- measure
- 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
- timeFrame
- duration of protocol
- description
- Assessment of thermal damage outside of intended treatment areas as measured by post contrast MRI, and the frequency of other adverse events and complications.
Secondary outcomes (2)
- measure
- To determine changes in imaging and biopsy characteristics after thermal ablation of prostate cancer.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * 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. * 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. 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.
References
Publications (1)
- DERIVEDEsengur 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. PMID 39426916