Focal Laser Ablation for Prostate Cancer

Overseen By Deb Berg

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Metal implant, Other malignancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a laser treatment guided by MRI to target and destroy cancer cells in patients with low-risk prostate cancer. The laser heats up and kills the cancer cells in a precise area, making it a less invasive option compared to surgery or radiotherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Focal Laser Ablation for Prostate Cancer?

Focal laser ablation is a promising treatment for prostate cancer that aims to target and destroy cancerous tissue while minimizing side effects compared to more extensive treatments. Initial studies suggest it is safe and may help control cancer in the short term, but long-term effectiveness is still being evaluated. ^{1 2 3 4 5}

Is focal laser ablation for prostate cancer safe?

Focal laser ablation for prostate cancer has been studied in several trials, primarily focusing on its safety. These studies suggest that it is generally safe for treating low to intermediate-risk prostate cancer, with a focus on preserving sexual and urinary function while minimizing side effects. ^{1 2 3 4 6}

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

Focal laser ablation is unique because it targets only the cancerous part of the prostate, using heat to destroy cancer cells while sparing healthy tissue. This approach, guided by real-time MRI, aims to reduce side effects like sexual and urinary dysfunction compared to traditional whole-gland treatments. ^{1 2 3 5 6}

Research Team

David Woodrum, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Men over 45 with low to intermediate-risk prostate cancer can join this trial. They should have a PSA level of 20 ng/mL or less, a Gleason score up to 7, and no more than three small cancer spots on their prostate that match MRI scans. Participants need to be able to handle anesthesia and give informed consent.

Inclusion Criteria

I am a man aged 45 or older.

My breast cancer is in an early stage, but larger than 2 cm.

I have been diagnosed with prostate cancer.

Exclusion Criteria

Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.

I have had cancer other than skin cancer in the last 3 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI-guided focal laser ablation using the Visualase Thermal Therapy System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including short- and long-term complications

3 years

Treatment Details

Interventions

• Focal laser ablation of the prostate

Trial Overview The study is testing the safety and effectiveness of using MRI-guided laser heat (LITT) for treating small areas of cancer in the prostate without affecting the rest of it.

Participant Groups

Group I: Single arm study Experimental Treatment 1 Intervention

MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

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

Laser ablation as focal therapy for prostate cancer. [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

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

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

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