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
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
More Related Trials
-
Focal Laser Ablation of Prostate Tissue
NCT02357121 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
NCT05616650 ·Status: RECRUITING ·Phase: PHASE2
-
Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
NCT01226576 ·Status: COMPLETED ·Phase: NA
-
High Intensity Focused Ultrasound in Prostate Cancer
NCT06402357 ·Status: RECRUITING ·Phase: PHASE2
-
Pilot Study on Focal Prostate Radio-Frequency Ablation
NCT01423006 ·Status: COMPLETED ·Phase: NA
-
Outcomes of Focal Ablation for Prostate Cancer
NCT05478694 ·Status: RECRUITING
-
Focal Prostate Radiofrequency Ablation
NCT02294903 ·Status: UNKNOWN ·Phase: NA
-
MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
NCT00805883 ·Status: COMPLETED ·Phase: PHASE1
-
Laser Based Focal Ablation of Low Grade Prostate Cancer
NCT01192438 ·Status: COMPLETED ·Phase: NA
-
Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
NCT02600156 ·Status: COMPLETED ·Phase: NA
-
Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer
NCT04045756 ·Status: UNKNOWN ·Phase: NA
-
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
NCT04808427 ·Status: RECRUITING ·Phase: NA
-
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
NCT00988130 ·Status: UNKNOWN ·Phase: PHASE2
-
MRI Guided Prostate Cancer Focal Laser Ablation
NCT03634579 ·Status: TERMINATED ·Phase: NA
-
High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer
NCT00561314 ·Status: COMPLETED ·Phase: PHASE2
-
MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer
NCT00448695 ·Status: COMPLETED ·Phase: PHASE1
-
MRI-guided Focal Laser Ablation Prostate Cancer
NCT05370482 ·Status: UNKNOWN ·Phase: NA
-
Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device
NCT02524860 ·Status: UNKNOWN ·Phase: NA
-
Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness
NCT07339943 ·Status: RECRUITING ·Phase: NA
-
Focal Prostate Radio-Frequency Ablation
NCT02328807 ·Status: COMPLETED ·Phase: NA
-
Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy
NCT03982706 ·Status: UNKNOWN
-
Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device
NCT02662673 ·Status: COMPLETED ·Phase: NA
-
MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
NCT02680535 ·Status: COMPLETED ·Phase: NA
-
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
NCT06178354 ·Status: RECRUITING ·Phase: NA
-
Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
NCT00318240 ·Status: COMPLETED ·Phase: NA