MRI Guided Focal Laser Ablation Treatment for Low and Intermediate Risk Prostate Cancer in Men Aged 40 to 80

What this Trial Is About

This research aims to evaluate the use of MRI guided Focal Laser Ablation MRgFLA in men with early stage, low to intermediate risk prostate cancer. The study focuses on determining how well MRgFLA can control prostate cancer while reducing the need for more invasive treatments like surgery or radiation. Previous studies suggest that MRgFLA may be a safe option with minimal side effects and help many patients avoid radical therapies over several years. Participants will receive focal laser ablation treatment guided by MRI, targeting the visible tumor with a margin around it to ensure thorough treatment. This is a single arm study where all patients will undergo the MRgFLA procedure using The TRANBERGCLSThermal Therapy device. After treatment, patients will have follow-up MRI scans and prostate biopsies at 6 months and 2 years, along with regular PSA blood tests to monitor cancer status. During the study, researchers will assess the presence of clinically significant prostate cancer using MRI and biopsy results. Patients will also complete validated questionnaires measuring urinary and sexual function before and at several points after treatment to track quality of life changes. The total monitoring period includes evaluations at 6 months, 12 months, and 24 months after treatment, allowing detailed assessment of treatment effects and safety over time.

MRI Guided Focal Laser Ablation of Prostate Cancer