The Safety and Efficacy of Irreversible Electroporation for the Ablation of Prostate Cancer Assessed by Procedural Related Side Effects and Post Prostatectomy Histology: A Prospective Human In-Vivo Study.
Inclusion Criteria:
1. Older than 50 years
2. Histologically confirmed organ-confined prostate cancer (clinical stage T1-T2)
3. Gleason score ≤7
4. Prostate Specific Antigen < 20 ng/ml
5. Able to visualize prostate gland adequately on transrectal US imaging during
enrolment evaluation
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
1. Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial
thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/microliter (uL)
2. Active urinary tract infection (UTI)
3. History of bladder neck contracture
4. Anaesthesia Surgical Assignment, category IV or greater
5. History of inflammatory bowel disease
6. Concurrent major debilitating illness
7. Prior or concurrent malignancy
8. Cardiac History
9. Implantable cardioverter-defibrillator (ICD) / Pacemaker
2. Prior or current therapies
1. Biologic therapy for prostate cancer
2. Chemotherapy for prostate cancer
3. Hormonal therapy for prostate cancer within 3 months of procedure
4. Radiotherapy for prostate cancer
5. Transurethral prostatectomy (TURP), urethral stent
6. Prior major rectal surgery (except haemorrhoids)
7. 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