A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer

This is a prospective multi-centre trial in 5 hospitals in 3 countries to investigate the efficacy and complications of targeted Microwave Ablation as a minimally invasive focal therapy for prostate cancer. Men aged 50-75 with PSA < 20ng/mL and clinically significant prostate cancer with 1-2 MRI lesions ≤15mm and ISUP grade group ≤3 will be recruited. Transperineal targeted Microwave Ablation of the prostate tumor(s) will be done with repeated ablations by a single microwave needle guided by MRI-Ultrasound fusion and organ-based tracking navigation. The primary outcome is any clinically significant prostate cancer detected on biopsy of treated area(s) per patient at 6 months.

Inclusion criteria

• Men aged between 45 - 75 years
• Life expectancy > 10 years upon recruitment
• Able to understand the trial and can provide informed and written consent, dated and signed before the enrollment and before any exam required by the trial
• Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
• Organ-confined prostate cancer on MRI
• PSA < 20 ng/mL
• 1-2 MRI visible lesion present and size ≤15mm, with targeted biopsy showing:

• ISUP grade group 2 or 3, or
• ISUP grade group 1 with tumor size ≥10mm

Exclusion criteria

• Patients not fit for general or spinal anaesthesia
• Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of <50 ml/min)
• Patients with coagulopathy that cannot be corrected
• Patients on anticoagulants or antiplatelets that cannot be stopped (Low dose Aspirin, e.g. 80-100mg, is acceptable and no need to stop before or during TMA treatment)
• Patients with previous treatment of prostate cancer
• Patients with prior pelvic radiotherapy for prostate cancer or other cancer
• Patients with maximal length of target lesion >15mm
• Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI
• . Patients with >2 areas (MRI-visible or invisible) of prostate cancer
• Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
• Patients with systematic cores showing any Gleason 4 pattern PCa which are not adjacent to the target lesions (1 core of pure Gleason 3 pattern PCa on systematic cores in contralateral lobe is acceptable)
• Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable)
• Patients with bladder pathology including bladder stone and bladder cancer
• Patients with known urethral stricture
• Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection.