Targeted Microwave Ablation for Localized Prostate Cancer
A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer Using Organ Based Tracking (OBT) Navigation
This study is testing a new treatment called Targeted Microwave Ablation to see if it can effectively treat localized prostate cancer in men aged 50-75.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT06262633 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of Targeted Microwave Ablation (TMA) combined with MRI-Ultrasound fusion and organ-based tracking navigation for treating localized prostate cancer. Conducted across five hospitals in three countries, it aims to assess the efficacy and complications of this minimally invasive focal therapy. Eligible participants include men aged 50-75 with clinically significant prostate cancer and specific MRI characteristics. The primary outcome will be the detection of any clinically significant prostate cancer in the treated areas at six months post-procedure.
Who should consider this trial
Good fit: Ideal candidates are men aged 50-75 with localized low or intermediate risk prostate cancer and specific MRI findings.
Not a fit: Patients with advanced prostate cancer, significant comorbidities, or those unable to undergo MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for localized prostate cancer, potentially improving patient outcomes and quality of life.
How similar studies have performed: While there is emerging interest in microwave ablation for prostate cancer, this specific approach using MRI-Ultrasound fusion is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shatin
- Peter Ka-Fung CHIU — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Peter Ka-Fung CHIU, PhD,MBChB — Chinese University of Hong Kong
- Study coordinator: Peter Ka-Fung CHIU, PhD,MBChB
- Email: peterchiu@surgery.cuhk.edu.hk
- Phone: 35052625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.