Outcome of localized intermediate risk Prostate cancer in Focal therapy Prostate cancer, Focal therapy, Transperineal Targeted Microwave Ablation (TMA)
Conditions
Interventions
TMA is given using the Biomedical TATO3 Microwave needle thermoablation
device under Organ-based Tracking (OBT) mechanism
Experimental Procedure/Surgery
localized intermediate risk Prostate cancer
Sponsors
Division of Urological Surgery, Faculty of Medicine, Siriraj hospital
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men aged more than 50 years old 2. Life expectancy more than 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 intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy 5. Organ-confined prostate cancer on MRI 6. PSA more than 20 ng/mL 7. at least 1 MRI visible lesion present with maximal tumor dimension Lower than 15mm, with targeted biopsy showing: ISUP grade group 2 or 3 PCa Systematic biopsies showing grade group 1-3 PCa just next to the MRI lesion is allowed Systematic biopsies showing grade group 1 PCa far away from the lesion is allowed
Exclusion criteria
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) lower than 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 more than 15mm 8. Patients with MRI lesion within 10mm from rectum or 10mm from sphincter on MRI 9. Patients with more than 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 Gleason 3 pattern PCa on systematic cores in contralateral lobe is acceptable) 12. Patients with definite extracapsular disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable) 13. Patients with bladder pathology including bladder stone or bladder cancer 14. Patients with known urethral stricture 15. Men aged lower than 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant cancer detection rate on confirmatory biopsies of treated area(s) at 12 months after end of the intervention Percentage of positive biopsies | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event, complication at 3,6,9, 12 months after the intervention Percentage of adverse event and complication | — |
Countries
Thailand
Contacts
Public ContactVarat Woranisarakul
Faculty of Medicine, Siriraj Hospital, Mahidol University.
Outcome results
None listed