A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT06262633
- Lead Sponsor
- Chinese University of Hong Kong
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 103
-
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
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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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The oncological control of prostate cancer At 6 months after treatment Any cancer detected on biopsy of each ablated area
- Secondary Outcome Measures
Name Time Method Urinary Symptoms after treatment At baseline, 3 Month, 6 Month and 12 Month Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)
Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity At baseline, 3 Month, 6 Month and 12 Month Rectal toxicity of treatment using Common Terminology Criteria for Adverse Events
Quality of life in patients with prostate cancer measured by EPIC-26 At baseline, 3 Month, 6 Month and 12 Month Quality of life in patients with prostate cancer measured by EPIC-26 range 0-100, the higher score the better the quality of life
Sexual side effects after treatment At baseline, 3 Month, 6 Month and 12 Month Sexual side effects, up to 1 year, measured by IIEF-5 score (ranging from 1-25), the lower the worse
Continence side effects after treatment At baseline, 3 Month, 6 Month and 12 Month Continence side effects, up to 1 year, measured by EPIC-26 questionnaire, the higher score the lower score the worse
PSA change At baseline, 3 Month and 6 Month and 12 Month PSA change after treatment
Common Terminology Criteria for Adverse Events (CTCAE) v5.0 At 3 Month, 6 Month and 1 year Complications of treatment using Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Quality of life measured by QLQ-C30, At baseline, 3 Month, 6 Month and 12 Month Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life
Cancer detection on biopsy of each ablated MRI visible lesion At 6 months after treatment Cancer detection on biopsy of each ablated MRI visible lesion
Cancer detection on biopsy of each ablated MRI invisible lesion At 6 months after treatment Cancer detection on biopsy of each ablated MRI invisible lesion
Gleason 4 or 5 cancer detected on biopsy of ablated area At 6 months after treatment The higher the Gleason score, the higher grade the prostate cancer
Out-of-field recurrence: Any cancer outside treated area on systematic biopsy At 6 months after treatment Out-of-field recurrence: Any cancer outside treated area on systematic biopsy
Quality of life measured by ED-5Q-5Lquestionnaire At baseline, 3 Month, 6 Month and 12 Month Quality of life measured by ED-5Q-5L questionnaire, the higher the score the better in quality of life
Trial Locations
- Locations (1)
Peter Ka-Fung CHIU
🇭🇰Sha Tin, Hong Kong
Peter Ka-Fung CHIU🇭🇰Sha Tin, Hong KongPeter Ka-Fung CHIU, PhD,MBChBContact35052625peterchiu@surgery.cuhk.edu.hk