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

NCT06047509 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-02-25

No results posted yet for this study

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

Interventions

PROCEDURE

Focal Laser Ablation

Removal of cancerous tissue through the direct application of laser energy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Wayne Brisbane, MD · University of California at Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2026-01-13
Completion
2026-01-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06047509 on ClinicalTrials.gov