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

Launched by CHINESE UNIVERSITY OF HONG KONG · Feb 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Targeted Microwave Ablation (TMA) for men with localized prostate cancer. The goal is to see how effective this treatment is when guided by advanced imaging techniques, specifically MRI combined with ultrasound. The trial is currently looking for participants, particularly men aged 45 to 75 who have been diagnosed with low to intermediate risk prostate cancer. To be eligible, participants must have a life expectancy of over 10 years, and their cancer should be confined to the prostate and visible on MRI.

If you or someone you know is considering joining this trial, participants can expect to receive the TMA treatment and undergo regular monitoring to assess its effectiveness. It’s important to note that certain health conditions may prevent eligibility, such as issues with anesthesia or specific types of prostate cancer. Overall, this trial aims to offer a potential new option for treating localized prostate cancer while providing valuable information about its safety and effectiveness.

Gender

MALE

Eligibility criteria

• 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.