Prostate Cancer
Conditions
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.
Interventions
DEVICETargeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The oncological control of prostate cancer | At 6 months after treatment | Any cancer detected on biopsy of each ablated area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| PSA change | At baseline, 3 Month and 6 Month and 12 Month | PSA change after treatment |
| 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) |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
Countries
Hong Kong
Contacts
Primary ContactPeter Ka-Fung CHIU, PhD,MBChB
Outcome results
None listed