AI-Powered Research

1. Life expectancy > 10 years
2. Histologically confirmed organ-confined prostate cancer (clinical stage T1-T2)
3. Gleason score *7
4. PSA <20 ng/ml
5. Able to visualize prostate gland adequately on transrectal US imaging
6. No prostate calcification greater than 5 mm
7. Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure

Exclusion Criteria

1. Other Conditions/Status:
a) Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/uL
b) Active urinary tract infection (UTI)
c) History of bladder neck contracture
d) Anaesthesia Surgical Assignment, category IV
e) History of inflammatory bowel disease
f) Concurrent major debilitating illness
g) Prior or concurrent malignancy
h) Cardiac History
i) ICD / Pacemaker
2. Prior or current therapies
a) Biologic therapy for prostate cancer
b) Chemotherapy for prostate cancer
c) Hormonal therapy for prostate cancer within 3 months of procedure
d) Radiotherapy for prostate cancer
e) Transurethral prostatectomy (*TURP*), urethral stent
f) Prior major rectal surgery (except haemorrhoids)
g) Inability or unwillingness to tolerate temporary cessation of concurrent anticoagulation therapy or anti-platelet drugs for a period of 7days prior to procedure and up to 7 days after procedure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a) To determine if the IRE ablation procedure is safe as measured by the<br /><br>composite number of procedural, device and post procedural adverse events<br /><br>measured with the CTCAE proforma.<br /><br>b) To determine if complete ablation of the specified targeted ablation zone is<br /><br>achieved as measured by histopathology assessment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>a) To determine if procedural side effects associated with current treatments<br /><br>for prostate cancer, mainly incontinence, erectile dysfunction and bowel damage<br /><br>are avoided as measured by the validated prostate cancer scores *EPIC, IIEF-5<br /><br>and IPSS or time of CAD required.<br /><br>b) To determine patient satisfaction and comfort measured by Patient<br /><br>Satisfaction Questionnaire, post procedural pain management and pain scores,<br /><br>time to ambulation, length of hospital stay.<br /><br>c) To determine accurateness of ablation zone detection by MRI/CEUS.</p><br>