Prostate CancerNCT06047509
Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance
A study testing Focal Laser Ablation in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal Laser Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- Androgen deprivation therapy
- Focal Laser Ablation (acceptable for enrolled subjects under consideration for repeat FLA)
- Prior prostate, bladder neck, or urethral stricture surgery
- Any prostate debulking procedure, including transurethral resection of prostate, photovaporization, or electrovaporization
- Transurethral incision of bladder neck
- Urethral stricture dilation or reconstruction
- Use of 5-alpha reductase inhibitors within 6 months of treatment
- Prior significant rectal surgery (hemorrhoidectomy is acceptable)
- Active rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
- Active inflammatory bowel disease
- Urinary tract or rectal fistula
- Previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery.
- Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis, MRI-unsafe aneurysm clips)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095-1406
About this study
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.
Read the detailed description
The Avenda Health FocalPoint System (K201687) is a laser-based interstitial irradiation/thermal soft-tissue ablation system that is FDA 510(k) cleared for surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialties. The Avenda Health Unfold-AI Software (K221624) is an Artificial Intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow that is also FDA 510(k) cleared. The Unfold-AI Software will be utilized along with the FocalPoint System and is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. This feasibility investigation will determine whether the FocalPoint System used with Unfold-AI can be used to ablate prostate tissue in men with prostate cancer while leaving critical structures (urethra, rectal wall) undamaged.
This is an open-label feasibility/pilot study to evaluate the safety and feasibility of the FocalPoint System with Unfold-AI. In this study, the investigators intend to use the Unfold-AI 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. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region. 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 HRQOL questionnaires. Post-treatment MRI findings, fusion biopsy results and biomarker (PSA) kinetics will also be monitored. Subjects eligible for repeat FLA (re-ablation) are those who still continue to meet Inclusion and Exclusion Criteria at Months 6 or 12 post-FLA treatment (See Sections 3.0 Inclusion Criteria, 4.0 Exclusion Criteria, and 6.4.7 Repeat FLA (re-ablation)). Subjects may undergo only one re-ablation on the study.
This study will cover pre-treatment through 12 months following FLA treatment or repeat FLA (re-ablation) treatment. The study also has a long-term follow-up data collection period of up to 10 years following a subject's last study visit.
The primary endpoint will be safety. Safety will be determined by the number, type, and severity of adverse events incurred by subjects.
- Conditions
- Prostate Cancer
- Being tested
- Focal Laser Ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Laser AblationProcedure or surgery
Also called FLA
Removal of cancerous tissue through the direct application of laser energy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Focal Laser Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start14 Sep 2023
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Wayne Brisbane, MD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047509
- Sponsor's protocol ID
- 22-001942
- Other IDs
- 5R01CA218547
- Status last verified
- Feb 2026
- First submitted
- 14 Sep 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance
- ClinicalTrials.gov ID
- NCT06047509
- Acronym / sponsor ID
- 22-001942
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Avenda Health FocalPoint System (K201687) is a laser-based interstitial irradiation/thermal soft-tissue ablation system that is FDA 510(k) cleared for surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialties. The Avenda Health Unfold-AI Software (K221624) is an Artificial Intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow that is also FDA 510(k) cleared. The Unfold-AI Software will be utilized along with the FocalPoint System and is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. This feasibility investigation will determine whether the FocalPoint System used with Unfold-AI can be used to ablate prostate tissue in men with prostate cancer while leaving critical structures (urethra, rectal wall) undamaged.
This is an open-label feasibility/pilot study to evaluate the safety and feasibility of the FocalPoint System with Unfold-AI. In this study, the investigators intend to use the Unfold-AI 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. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region. 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 HRQOL questionnaires. Post-treatment MRI findings, fusion biopsy results and biomarker (PSA) kinetics will also be monitored. Subjects eligible for repeat FLA (re-ablation) are those who still continue to meet Inclusion and Exclusion Criteria at Months 6 or 12 post-FLA treatment (See Sections 3.0 Inclusion Criteria, 4.0 Exclusion Criteria, and 6.4.7 Repeat FLA (re-ablation)). Subjects may undergo only one re-ablation on the study.
This study will cover pre-treatment through 12 months following FLA treatment or repeat FLA (re-ablation) treatment. The study also has a long-term follow-up data collection period of up to 10 years following a subject's last study visit.
The primary endpoint will be safety. Safety will be determined by the number, type, and severity of adverse events incurred by subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm I Treatment | Experimental | Procedure: Focal Laser AblationAfter 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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*
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal Laser AblationAlso: FLARemoval of cancerous tissue through the direct application of laser energy | Procedure or surgery | Arm I Treatment |
Primary outcome
Adverse event monitoring
Time frame: up to 12 months post treatment
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.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Brisbane, MD principal investigator
University of California at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal Laser Ablation in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event monitoring (time frame: up to 12 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.