Focal Laser Ablation for Prostate Cancer

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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the safety and feasibility of Magnetic-Resonance(MR)-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events.

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 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, whether guided by MRI or MRI-ultrasound fusion. ^{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, showing it can be performed with low risk of side effects, preserving sexual and urinary function, and is feasible both in specialized imaging units and urology clinics. ^{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 3 5 6}

Research Team

Allan Pantuck, M.D.

Principal Investigator

University of California at Los Angeles

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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. Australia pubmed.ncbi.nlm.nih.gov

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

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

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

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]