Focal Laser Ablation for Prostate Cancer

Overseen By Ankush Sachdeva

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Anticoagulants, NSAIDs, 5-alpha reductase

Disqualifiers: Significant cancer, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a laser device called the FocalPoint System, guided by UnfoldAI software, to treat prostate cancer. The software identifies cancer areas using MRI images, and the laser targets and destroys these areas. This method aims to treat men with prostate cancer while protecting nearby healthy structures.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before the procedure. If you are on anticoagulants (blood thinners) like coumadin, you must stop them for at least 7 days before the procedure. Aspirin should be stopped for at least 14 days, and NSAIDs, Vitamin E, multivitamins, and herbal products should be stopped for at least 7 days before the procedure.

What data supports the effectiveness of the treatment Focal Laser Ablation for prostate cancer?

Research shows that focal laser ablation (FLA) can effectively treat low to intermediate risk prostate cancer while preserving sexual and urinary function with fewer side effects compared to more extensive treatments. Studies also indicate that FLA is safe and feasible, with promising cancer control outcomes after 6 months. ^{1 2 3 4 5}

Is focal laser ablation safe for treating prostate cancer?

Focal laser ablation has been studied for safety in treating prostate cancer, with trials showing it can be performed safely in both MRI units and urology clinics. It aims to treat cancer while minimizing side effects, such as preserving sexual and urinary function. ^{1 2 3 4 5}

How is focal laser ablation treatment different from other prostate cancer treatments?

Focal laser ablation is unique because it targets only the specific area of the prostate affected by cancer, using heat to destroy cancer cells while sparing healthy tissue. This approach, guided by real-time MRI, aims to reduce side effects compared to traditional treatments that affect the entire prostate gland. ^{1 2 4 5 6}

Research Team

Wayne Brisbane, MD

Principal Investigator

University of California at Los Angeles

Eligibility Criteria

Men aged 40-85 with organ-confined prostate cancer (stage ≤ T2b, Gleason score =7), who have a prostate size of 20cc to 80cc and desire focal therapy over conventional treatments. They must have had an MRI showing a suspicious area and confirmed adenocarcinoma from targeted biopsy cores within the last six months.

Inclusion Criteria

My cancer was confirmed through a biopsy.

My prostate cancer is contained within the prostate and not severe.

My prostate size is between 20cc and 80cc.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo focal laser ablation (FLA) of prostate cancer using the FocalPoint System with Unfold-AI for guidance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and quality of life at 1 week, 1 month, and every 3 months until one year post-treatment

12 months

Multiple visits (in-person)

Long-term follow-up

Long-term data collection up to 10 years following the last study visit

Up to 10 years

Treatment Details

Interventions

• Focal Laser Ablation

Trial Overview The trial is testing the FocalPoint System with UnfoldAI software for treating prostate cancer by using laser ablation guided by MRI/US image fusion. The safety and feasibility are being evaluated through follow-ups including adverse event monitoring and quality-of-life assessments for one year post-treatment.

Participant Groups

Group I: Arm I Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Focal laser ablation is a safe and feasible treatment for intermediate risk prostate cancer, with no serious adverse events reported in a trial involving 8 men over 6 months.

While the treatment successfully reduced prostate-specific antigen levels in 7 out of 8 participants, follow-up biopsies indicated that larger treatment margins may be necessary for complete tumor ablation, as cancer was still detected outside the treated area in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial. Natarajan, S., Raman, S., Priester, AM., et al.[2018]

Focal laser ablation for prostate cancer can be safely performed in a urology clinic using MRI-ultrasound fusion guidance, with 10 out of 11 patients successfully treated under local anesthesia and no significant adverse events reported.

At 6 months post-treatment, imaging and biopsies showed varying results in cancer presence, indicating that while the procedure is feasible, further research is needed to optimize treatment margins and assess long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Feasibility of Magnetic Resonance Imaging-Ultrasound Fusion for Guidance. Natarajan, S., Jones, TA., Priester, AM., et al.[2019]

Focal laser ablation (FLA) is a promising treatment for low-risk prostate cancer that effectively targets cancerous areas while minimizing damage to surrounding tissues, leading to fewer side effects compared to traditional therapies.

Current phase I clinical trials indicate that FLA provides accurate and reproducible ablation zones, and its effectiveness is being further evaluated in ongoing phase II trials, highlighting its potential as a well-tolerated treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser ablation as focal therapy for prostate cancer. Wenger, H., Yousuf, A., Oto, A., et al.[2021]

Focal therapy for prostate cancer targets specific areas of the prostate with clinically significant disease, leading to reduced treatment-related side effects, although long-term cancer control is still being studied.

Focal laser ablation, which is compatible with real-time MRI, shows promise as a treatment option, supported by initial experiences with 23 patients and ongoing research into candidate selection and future applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. Lee, T., Mendhiratta, N., Sperling, D., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Feasibility of Magnetic Resonance Imaging-Ultrasound Fusion for Guidance. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Results in 120 Patients with Low- to Intermediate-Risk Disease. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

Magnetic resonance image-guided focal laser ablation in clinically localized prostate cancer: safety and efficacy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Laser ablation as focal therapy for prostate cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. [2021]