Focal Laser Ablation for Prostate Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Jonsson Comprehensive Cancer Center

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

Disqualifiers: Bleeding disorder, Urinary infection, others

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

Compensation: Varies

Number of Visits: 2

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 a special laser technique called Focal Laser Ablation. The goal is to determine if this method, which targets cancerous areas of the prostate with heat, is safe and practical. It is specifically for men with prostate cancer that hasn't spread and who seek alternatives to surgery or radiation. Participants should have had a recent MRI scan and a biopsy confirming their cancer type. This study will help researchers understand any side effects and assess the treatment's effectiveness. As an Early Phase 1 trial, participants will be among the first to receive this innovative treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulants (blood thinners) like coumadin for at least 7 days around the procedure. If you are on 5-alpha reductase inhibitors, you must stop them at least 6 months before treatment.

What prior data suggests that this method is safe for prostate cancer treatment?

Research has shown that focal laser ablation (FLA) for prostate cancer is generally safe. Studies found that only about 3% of patients experienced serious side effects, indicating that most people tolerate the treatment well. This procedure uses a laser, guided by MRI images, to target and destroy cancer cells in the prostate. Although early studies are encouraging, concerns exist about the design of the trials and the data collected. Nevertheless, the low rate of severe side effects remains reassuring for now. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Focal Laser Ablation for prostate cancer because it offers a targeted approach that minimizes damage to healthy tissue. Unlike traditional treatments like surgery or radiation, which can affect the entire prostate, this method uses the Orion system to precisely apply thermal energy to cancerous areas identified by MRI and confirmed with a biopsy. This targeted approach not only aims to effectively eliminate cancerous cells but also potentially reduces side effects and recovery time, making it a promising alternative for patients.

What evidence suggests that this focal laser ablation is effective for prostate cancer?

Research has shown that Focal Laser Ablation (FLA) for prostate cancer is promising. In one study, about 80% of men treated with FLA showed no significant cancer in follow-up tests. Another study found that 83% of patients did not require further treatment within a year and experienced few side effects. Over five years, 82% of patients avoided more invasive treatments, with only a small number experiencing serious side effects. These findings suggest that FLA, the treatment under study in this trial, could effectively target and treat prostate cancer while minimally impacting quality of life. ^{2 4 6 7 8}

Who Is on the Research Team?

Allan Pantuck, M.D.

Principal Investigator

University of California at Los Angeles

Are You a Good Fit for This Trial?

Men aged 40-85 with untreated, organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7), who have had a recent MRI and biopsy confirming the diagnosis. They should want focal therapy over conventional treatments and have a prostate size between 20cc to 80cc. Excluded are those with bleeding disorders, on anticoagulants that can't be stopped, prior prostate cancer treatments, significant rectal or urinary conditions, or contraindications to MRI.

Inclusion Criteria

I had a detailed prostate biopsy with more than 12 samples taken, based on MRI results, within the last 6 months.

Multi-parametric MRI at University of California at Los Angeles (UCLA) within 6 months of study treatment, demonstrating a Region of interest (ROI) of MRI (PIRADSv2 > Grade 3) and prostate volume 20cc to 80cc

I am between 40 to 85 years old with early-stage prostate cancer.

Exclusion Criteria

I have not had any previous treatments or surgeries for prostate cancer that would interfere with new treatments.

I do not have any health conditions that would make it unsafe for me to join.

I can stop my blood thinner medication for at least 7 days if needed for a procedure.

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 of prostate cancer using the Orion System, guided by MRI/ultrasound image fusion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and complete HRQOL questionnaires at 1 week, 1 month, and every 3 months until one year post-treatment

12 months

1 week, 1 month, and every 3 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Focal Laser Ablation

Trial Overview The trial is testing the safety and feasibility of using MR-ultrasound fusion-guided Focal Laser Ablation (FLA) for treating prostate cancer with the Orion System. This method aims at precisely targeting and destroying cancerous tissue in the prostate while sparing healthy areas.

How Is the Trial Designed?

Group I: Focal Laser Ablation Experimental Treatment 1 Intervention

The Orion system will be used to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy.

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 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]

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]

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 We found that focal ablation of localized prostate cancer (PCa) is effective, with about 80% of men showing no significant cancer in biopsies ...

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06916013

NCT06916013 | Focal Laser Ablation in Prostate Cancer Many groups have published limited data on outcomes following in-bore MRI-guided focal therapy, and many others are actively engaged or considering prospective ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2588931125000392

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%).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37491432/

Functional outcomes and safety of focal therapy for ... FT is a promising treatment for localized PCa, achieving excellent results in terms of safety and functional outcomes.

7. 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 ...

8. beonbrand.getbynder.com beonbrand.getbynder.com/m/4d7fa873eac6807c/original/Focal-Laser-Ablation-of-Prostate-Cancer.pdf

Focal Laser Ablation of Prostate Cancer [48] Despite these "positive" results, an FDA staff analysis cited issues with the trial design, endpoints, missing data, and adverse events of ...