102 Participants Needed

Focal Laser Ablation for Prostate Cancer

(MRgFLA Trial)

SG
KC
KC
Overseen ByKateri Corr, RPN
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This clinical research study is designed to determine the ability of in bore MRI guided Focal Laser Ablation (MRgFLA) in patients with early stage carcinoma of prostate. The results will be evaluated by repeated MRI and prostate biopsy. Previous prospective development study demonstrated that FLA may be a viable option for men with low-intermediate risk prostate cancer. The vast majority of patients undergoing this treatment experienced minimal side effects with no peri-operative complications. Over 80% of patients treated with MRgFLA remain on AS and were able to avoid radical therapy at mean follow up duration of 3 years.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on androgen suppression therapy or chemotherapy for prostate cancer, you would not be eligible to participate.

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

Focal laser ablation is a developing treatment for prostate cancer that shows promise in reducing side effects compared to traditional treatments, and it can be performed with real-time MRI guidance. Although long-term effectiveness is not yet proven, early studies suggest it may help control cancer in the short term.12345

Is focal laser ablation for prostate cancer safe?

Focal laser ablation for prostate cancer has been studied in several trials, and no major adverse events were reported, indicating it is generally safe for humans.13678

How is the treatment Focal Laser Ablation for Prostate Cancer different from other treatments?

Focal Laser Ablation is unique because it uses real-time MRI guidance to precisely target and destroy only the cancerous part of the prostate, potentially reducing side effects compared to traditional treatments that affect the entire prostate.12346

Research Team

SG

Sangeet Ghai, MD

Principal Investigator

Director; Biopsy Centre, Abdominal Division and Joint Department of Medical Imaging

Eligibility Criteria

This trial is for men aged 40-80 with early-stage prostate cancer (Gleason score ≤ 7, primary grade ≤ 4) who have a life expectancy of over 10 years. Eligible participants must have an MRI showing a suspicious site that matches the location of cancer found in biopsy, PSA level under 15 ng/mL, and cancer confined to one lobe of the prostate.

Inclusion Criteria

My MRI and biopsy results match for cancer location in the prostate.
My doctors expect me to live more than 10 years, not counting my prostate cancer.
Prostate specific antigen (PSA) level less than 15 ng/mL
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MRI guided Focal Laser Ablation (MRgFLA) for prostate cancer

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with MRI and biopsy assessments

24 months
MRI and biopsy at 6 months and 24 months, PSA assessments at regular intervals

Treatment Details

Interventions

  • The TRANBERGCLS
Trial OverviewThe study tests MRgFLA's effectiveness for treating low-intermediate risk prostate cancer. It involves using MRI guidance to apply targeted laser therapy directly to the tumor. Success will be measured by follow-up MRIs and biopsies.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single arm prospective clinical trialExperimental Treatment1 Intervention
This is a single arm study where patients with low-intermediate risk MR visible locally confined prostate cancer will be treated with focal laser ablation under MRI guidance in the magnet. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months and at 2 years, with PSA assessment at regular intervals during the time

The TRANBERGCLS is already approved in United States for the following indications:

🇺🇸
Approved in United States as TRANBERG CLS for:
  • Soft tissue ablation (not specifically approved for prostate cancer)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Clinical Laserthermia Systems AB

Industry Sponsor

Trials
8
Recruited
150+

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.
Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial.Natarajan, S., Raman, S., Priester, AM., et al.[2018]
Focal therapy, specifically focal laser thermocoagulation, is a promising new treatment for prostate cancer that targets specific tumor regions, potentially leading to fewer side effects compared to traditional treatments.
This technique can be performed under real-time magnetic resonance imaging control, enhancing precision during the procedure, although long-term results are still needed to fully assess its efficacy.
[Focal laser thermocoagulation for localized prostate cancer].Glybochko, PV., Vinarov, AZ., Shpot, EV., et al.[2017]
In a phase II study involving 27 men with localized prostate cancer, 96% showed no evidence of cancer in the ablation zone at 3 months after undergoing magnetic resonance imaging guided focal laser ablation, indicating high short-term efficacy.
The procedure had an acceptable safety profile, with no significant changes in urinary symptoms and only a marginal decrease in sexual function at 1 and 3 months, suggesting that it may be a viable treatment option for select patients.
Phase II Evaluation of Magnetic Resonance Imaging Guided Focal Laser Ablation of Prostate Cancer.Eggener, SE., Yousuf, A., Watson, S., et al.[2018]

References

Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial. [2018]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Focal laser thermocoagulation for localized prostate cancer]. [2017]
Phase II Evaluation of Magnetic Resonance Imaging Guided Focal Laser Ablation of Prostate Cancer. [2018]
Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. [2021]
Complications, Recovery, and Early Functional Outcomes and Oncologic Control Following In-bore Focal Laser Ablation of Prostate Cancer. [2015]
Focal Laser Ablation of Prostate Cancer: Feasibility of Magnetic Resonance Imaging-Ultrasound Fusion for Guidance. [2019]
Real-time magnetic resonance imaging-guided focal laser therapy in patients with low-risk prostate cancer. [2022]
MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial. [2021]