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

This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.

Sex

Male

Minimum age

45 Years

Maximum age

75 Years

Inclusion Criteria:

1. Men aged between 45 - 75 years
2. Life expectancy \> 10 years upon recruitment
3. 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
4. Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
5. Organ-confined prostate cancer on MRI
6. PSA \< 20 ng/mL
7. 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:

1. Patients not fit for general or spinal anaesthesia
2. Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of \<50 ml/min)
3. Patients with coagulopathy that cannot be corrected
4. 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)
5. Patients with previous treatment of prostate cancer
6. Patients with prior pelvic radiotherapy for prostate cancer or other cancer
7. Patients with maximal length of target lesion \>15mm
8. Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI
9. . Patients with \>2 areas (MRI-visible or invisible) of prostate cancer
10. Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
11. 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)
12. Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable)
13. Patients with bladder pathology including bladder stone and bladder cancer
14. Patients with known urethral stricture
15. Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection.

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