Focal Laser Ablation for Prostate Cancer
(MRgFLA Trial)
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?
How is the treatment Focal Laser Ablation for Prostate Cancer different from other treatments?
Research Team
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MRI guided Focal Laser Ablation (MRgFLA) for prostate cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment with MRI and biopsy assessments
Treatment Details
Interventions
- The TRANBERGCLS
The TRANBERGCLS is already approved in United States for the following indications:
- 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
Clinical Laserthermia Systems AB
Industry Sponsor