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Trial Title:
A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer
NCT ID:
NCT06262633
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation
Description:
Targeted microwave ablation (TMA) is a novel treatment developed for focal treatment of
prostate cancer, and it is applied with precise navigation guidance under the organ-based
tracking (OBT) mechanism.
Arm group label:
Targeted Microwave Ablation (TMA)
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.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peter Ka-Fung CHIU
Address:
City:
Sha Tin
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Peter Ka-Fung CHIU, PhD,MBChB
Phone:
35052625
Email:
peterchiu@surgery.cuhk.edu.hk
Start date:
March 15, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06262633
