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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a new treatment called focal laser ablation to manage low-risk prostate cancer. The main goal is to determine if this treatment is safe and feasible when guided by an MRI (a type of body scan). Participants will undergo a procedure where a focused laser targets and heats cancer cells in the prostate. The trial seeks men diagnosed with early-stage prostate cancer who show specific tumor characteristics on MRI scans. It offers a chance to explore a less invasive option for managing prostate cancer. As an unphased trial, it provides an opportunity to contribute to innovative research and potentially benefit from a novel treatment approach.

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 prior data suggests that this technique is safe for treating prostate cancer?

Research has shown that using MRI to guide focal laser ablation (FLA) for treating prostate cancer is safe. Several studies have confirmed that this treatment is both feasible and safe. For example, one study found that FLA achieved excellent results without major problems over three years. Another study reported a promising short-term response with no major safety concerns. Overall, these findings suggest that MRI-guided focal laser ablation is well-tolerated by patients, with few side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Focal laser ablation is unique because it offers a minimally invasive option for treating prostate cancer, unlike traditional methods like surgery or radiation. This technique uses MR guidance to precisely target and destroy cancerous tissue with heat, reducing damage to surrounding healthy tissue. Researchers are excited about this treatment as it has the potential to preserve more of the prostate's normal function and reduce side effects, offering a promising alternative to more invasive procedures.

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

Research has shown that focal laser ablation (FLA) for prostate cancer is promising. One study found a significant drop in the average PSA level, a marker for prostate cancer, after treatment. Another study showed that 83% of men did not experience treatment failure over several years of follow-up. FLA safely targets and destroys cancerous tissue while being monitored in real-time. Overall, these findings suggest that FLA could be an effective option for treating low-risk prostate cancer. Participants in this trial will receive MR-guided focal laser ablation using the Visualase Thermal Therapy System. ^{1 2 3 6 7}

Who Is on the Research Team?

David Woodrum, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8136525/

MRI-guided focal laser ablation of prostate cancer Mean PSA significantly decreased after FLA (−2.5, p < 0.001). Seven out of 15 patients (46.67%) had residual cancer in, adjacent, or in close proximity to the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1051044325001381

MR-Guided Transrectal Focal Laser Ablation for Localized ... MR imaging–guided transrectal FLA appeared to be feasible and safe, and initial experience resulted in promising short-term oncologic response.

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

5-Year Outcomes Following Focal Laser Ablation of ... Results: Of the 36 men enrolled, 6 were ultimately lost to follow-up. Of the remaining 30, 25 (83%) have remained free from failure over a median follow-up of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03634579

MRI Guided Prostate Cancer Focal Laser Ablation Laser has been shown to produce homogenous tissue necrosis that can be monitored by real time temperature maps, a feature that facilitates effective and safe ...

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

Review Laser-focused ablative therapy for prostate cancer ... This section provides a comprehensive review of MRI-guided focal Laser ablation outcome for PCa, based on data from 325 patients in 10 studies reporting short ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34003127/

MRI-guided focal laser ablation of prostate cancer - PubMed Conclusion: After 3 years of follow-up we conclude focal laser ablation is safe and feasible without significant complications. MeSH terms. Follow-Up Studies ...

7. ajronline.org ajronline.org/doi/10.2214/AJR.17.19201

MRI Findings After MRI-Guided Focal Laser Ablation of ... The purpose of this study is to describe the quantitative and qualitative findings of multiparametric prostate MRI performed after MRI-guided focal laser ...