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

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About this study

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.

Condition
Prostate Cancer
Tested
Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation
Sponsor
Chinese University of Hong Kong

Who can join

Age
45 to 75 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 45 years
  • Maximum age: 75 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer
  • 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 15

  • 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.

Where

1 site, 1 recruiting

Peter Ka-Fung CHIU

Shatin, Hong Kong

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.