Microwave Needle Thermoablation for Treatment of Localized Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Focal therapy, Microwave ablation
Eligibility Criteria
Inclusion Criteria:
- Men aged between 45 - 75 years
- Life expectancy > 10 years upon recruitment
- Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
- Organ-confined prostate cancer on MRI
- PSA < 20 ng/mL
- At least 1 MRI visible lesion present and size ≤15mm, and Targeted biopsy showing Gleason score 6 (with cancer core length ≥6mm) or Gleason score 7 (3+4 or 4+3), With or without positive Systematic biopsy (out of 24 systematic cores) away from MRI visible target showing Gleason 6 cancer
Exclusion Criteria:
- Patients unfit for MRI exam or MR gadolinium contrast
- Patients with previous treatment of prostate 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 >3 areas (MRI-visible or invisible) of prostate cancer
- Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
- Patients with bladder pathology including bladder stone and bladder cancer
- Patients with urethral stricture
- Patients with neurogenic bladder and/or sphincter abnormalities
Sites / Locations
- Prince of Wales Hospital, Chinese University of Hong Kong
Arms of the Study
Arm 1
Experimental
Microwave needle thermoablation of prostate cancer
The treatment will be performed under general anaesthesia or monitored anaesthetic care using the Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France) under Organ-based Tracking® (OBT) mechanism of the Koelis Trinity® machine. Both Koelis Trinity and TATO3 are CE (European Conformity) marked in Europe. A transrectal sideview ultrasound probe is used for real-time imaging and OBT of the prostate. The TATO3® needle is inserted transperineally to the tumor under MRI-Ultrasound fusion OBT guidance with the treatment zone covering the whole tumor. The dominant MRI-visible lesion and up to 1-2 more MRI-visible or invisible lesion will be treated.