Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance

NCT06047509 | Terminated DMC FDA Device

• 2 other identifiers: 22-0019425R01CA218547
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label feasibility/pilot study to evaluate the safety and feasibility of the FocalPoint System with UnfoldAI. In this study, the investigators intend to use the UnfoldAI software to identify cancer margins and create ablation treatment plans and use the FocalPoint System to deploy and monitor thermal energy in cancerous regions of the prostate. Subjects will be assessed at 1 week, 1 month, and every 3 months until one-year post-FLA treatment(s) to be monitored for adverse events and complete quality-of-life questionnaires.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse event monitoring

  adverse event data will be monitored and tabulated. The primary study endpoint will be achieved by the absence of any Grade 3 or higher adverse events.

  up to 12 months post treatment

Study Arms (1)

Arm I Treatment

EXPERIMENTAL

After inserting the laser, a thermal-optical probe will be inserted via a multichannel needle guide or tranperineal grid in the prostate using transrectal ultrasound guidance. The sensor probe will be placed at a pre-determined depth and location based on the treatment zone. Targets will be identified prior to laser treatment using multi-parametric MRI and delineated by the radiologist for visualization by the treatment operator. The lesion will be visible both on a 3D reconstruction and during real-time ultrasound imaging. Applications of laser energy up to 15 watts of power will be used to treat the target region. Confirmation of appropriate laser position will be made with real-time ultrasound prior to application of laser energy and repeatedly during activation of the laser. Energy delivery will be planned specific to each patient's tumor geometry, with the assistance of the Avenda Health Unfold-AI Software.

Procedure: Focal Laser Ablation

Interventions

Focal Laser Ablation PROCEDURE

Removal of cancerous tissue through the direct application of laser energy

Also known as: FLA

Arm I Treatment

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: a prostate gland must be present
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7)
• Age 40 to 85 years of age
• Multi-parametric MRI read at study site within 9 months of study treatment, demonstrating a Region of interest (ROI) of MRI (PIRADSv2 \> Grade 3)1
• Prostate volume 20cc to 80cc
• MRI/ultrasound fusion biopsy with ≥ 10 systematic biopsy cores and ≥ 2 targeted biopsy cores from above MRI-derived ROI within 6 months of study treatment\*
• Histologically confirmed adenocarcinoma from targeted biopsy cores
• Overall Gleason = 3+4 or 4+3
• Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery, and hormone therapy)
• Treatment plan that allows for treatment of lesion while still maintaining a 4mm safety margin from the rectal wall and urethra
• Signed informed consent for the FLA treatment through follow-up per study protocol
• For subjects under consideration for repeat FLA, the post-treatment MRI and biopsies done at Months 6 and 12 study visits may be used for these criteria.

You may not qualify if:

• Any significant cancer outside of the intended treatment zone, defined as Gleason score ≥ 7
• \< 10 years life expectancy
• Any medical condition that would compromise the subject's ability to safely participate in the study
• Active bleeding disorder
• Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
• Use of aspirin, unless it can be temporarily stopped for a window of at least 14 days prior to FLA procedure
• Use of NSAIDS (except aspirin), Vitamin E, multivitamins, and herbal products, unless they can be temporarily stopped for at least 7 days prior to FLA procedure
• Active urinary tract infection
• Active prostate abscess, prostatitis, or neurogenic bladder
• Any prior treatment for prostate cancer, including:
• Radical prostatectomy
• Radiation therapy (external beam or brachytherapy)
• Cryotherapy
• High intensity focused ultrasound (HIFU) treatment
• Photodynamic therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095-1406, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Wayne Brisbane, MD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the investigators intend to use Focal Laser Ablation guided by the UnfoldAI software to identify cancer margins and create ablation treatment plans and use the FocalPoint System to deploy and monitor thermal energy in cancerous regions of the prostate.

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: September 14, 2023
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)