癌研連線CancerLink
Recruiting NCT06262633

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

Prostate CancerBladder / Urothelial CancerN/AEGFR

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.

Conditions: Prostate Cancer

Eligibility Criteria

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
  • 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.

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.