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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat prostate cancer using Focal Laser Ablation, which targets heat to destroy cancer cells. Researchers aim to determine the safety and effectiveness of this method with the help of special software that identifies cancerous areas. They seek men with prostate cancer confined to the gland who have not received treatments like surgery or radiation and prefer alternatives to conventional options. Participants will undergo regular check-ups to monitor their health and quality of life. As an unphased trial, this study offers a unique opportunity for patients to explore innovative treatment options beyond conventional methods.

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 prior data suggests that the FocalPoint System with UnfoldAI is safe for prostate cancer treatment?

Research has shown that Focal Laser Ablation (FLA) could be a promising treatment for prostate cancer. One study found that after a year, FLA had few side effects and did not greatly impact most patients' quality of life. Another study noted that FLA is generally well-tolerated, involves a short treatment time, and has few complications. While the treatment might not work for everyone, many patients did not need further treatment. Overall, FLA appears to be a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Focal Laser Ablation is unique because it targets prostate cancer directly using precise laser energy, minimizing damage to surrounding healthy tissue. Unlike standard treatments such as surgery or radiation, which can have broader side effects, this approach allows for a highly targeted intervention. Researchers are excited because the technique is guided by advanced imaging technologies, like multi-parametric MRI and real-time ultrasound, ensuring accurate targeting and potentially reducing complications. Additionally, the tailored energy delivery, aided by AI software, offers a personalized treatment plan based on each patient's tumor geometry.

What evidence suggests that the FocalPoint System with UnfoldAI is effective for prostate cancer?

Research has shown that Focal Laser Ablation (FLA), the treatment under study in this trial, is a promising option for prostate cancer. One study found that 83% of patients did not need additional treatment after one year, demonstrating its effectiveness in preventing cancer recurrence. Over five years, 82% of patients avoided more intense treatments, highlighting its long-term benefits. The procedure is minimally invasive, requiring only a small incision, and has a low complication rate, with serious side effects occurring in just 3% of cases. Patients reported no major changes in their quality of life after treatment, making it a well-tolerated option for many. ^{1 3 4 6 7}

Who Is on the Research Team?

Wayne Brisbane, MD

Principal Investigator

University of California at Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8503805/

Focal Laser Ablation of Prostate Cancer - PubMed Central - NIH At 1 year, FLA in selected patients has low morbidity, no significant changes in quality of life and 83% freedom of retreatment rate.

2. euoncology.europeanurology.com euoncology.europeanurology.com/article/S2588-9311(25)00039-2/fulltext

Outcomes of Focal Therapy for Localized Prostate Cancer Five-year radical and systemic treatment–free survival was 82% (95% CI: 75–88%). The pooled incidence of grade ≥3 AEs was 3% (95% CI: 2–5%). Pad ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211568425000725

Review Laser-focused ablative therapy for prostate cancer ... Focal Laser ablation is an effective, well-tolerated, minimally invasive treatment for prostate cancer, which offers short treatment time, low complication ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34090887/

5-Year Outcomes Following Focal Laser Ablation of ... Of the remaining 30, 25 (83%) have remained free from failure over a median follow-up of 71 months'. Among these patients, 10 (40%) developed in-field ...

5. nature.com nature.com/articles/s41598-020-65863-8

Comparative Effectiveness of Radiotherapy versus Focal ... A Phase II evaluation of FLA including 27 FLA-treated patients reported a favorable oncologic outcome within 1 year. The targeted biopsy of the ...

6. nature.com nature.com/articles/s41391-023-00783-y

A multi-center international study to evaluate the safety ... For men with localized prostate cancer, IRE could achieve good urinary and sexual function outcomes and a reasonable oncological result. The ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8740376/

A systematic review of outcomes after thermal and ... This study reported a relatively high (26%) treatment failure rate and is limited by the fact that two-third of the patients had low-risk disease. In 2015, ...