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

Last updated: May 4, 2025
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Prostate Cancer

Treatment

Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation

Clinical Study ID

NCT06262633
CRE-2023.079
  • Ages 45-75
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

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 andsigned before the enrollment and before any exam required by the trial

  4. Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasoundfusion 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

Exclusion Criteria:

  1. Patients not fit for general or spinal anaesthesia

  2. Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerularfiltration 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 doseAspirin, e.g. 80-100mg, is acceptable and no need to stop before or during TMAtreatment)

  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 fromsphincter 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 notadjacent to the target lesions (1 core of pure Gleason 3 pattern PCa on systematiccores in contralateral lobe is acceptable)

  12. Patients with definite cT3 or above disease on imaging (prostate capsular contactwithout 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.

Study Design

Total Participants: 103
Treatment Group(s): 1
Primary Treatment: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
June 30, 2026

Study Description

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.

Connect with a study center

  • Peter Ka-Fung CHIU

    Sha Tin,
    Hong Kong

    Active - Recruiting

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