Safety and Efficacy of Irreversible Electroporation in Ablation of Prostate Cancer in Humans

Study Overview
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Brief Summary
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Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using similar planning criteria, procedure protocol, instruments and software used for brachytherapy, a conventional targeted radiation therapy where radioactive seeds are implanted into prostate tumours. Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system. The volume of the prostate is measured and a specified ablation zone will be determined. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image guidance. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 week, 2 weeks post IRE, pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have their scheduled prostatectomy at approximately 30 days after the IRE procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological examination of the prostate by the Pathology Department and measured as complete or incomplete ablation. The primary outcome is safety as measured by the composite of procedural device and post procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required catheterization time and International Index of Erectile Function (IIEF) and efficacy of ablation determined by histological examination post prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS) pain score, time to ambulation, length of hospital stay.

Official Title
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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.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Irreversible Electroporation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with prostate cancer who are indicated to undergo a radical prostatectomy Life expectancy of > 10 years Able to visualize prostate gland adequately on transrectal US imaging during enrolment evaluation No prostate calcification greater than 5 mm Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure Exclusion Criteria: Other Conditions/Status Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/microliter (uL) Active urinary tract infection (UTI) History of bladder neck contracture Anaesthesia Surgical Assignment, category IV or greater History of inflammatory bowel disease Concurrent major debilitating illness Prior or concurrent malignancy Cardiac History Implantable cardioverter-defibrillator (ICD) / Pacemaker Prior or current therapies Biologic therapy for prostate cancer Chemotherapy for prostate cancer Hormonal therapy for prostate cancer within 3 months of procedure Radiotherapy for prostate cancer Transurethral prostatectomy (TURP), urethral stent Prior major rectal surgery (except haemorrhoids) 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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: peripheral ablation<br>an ablation of the peripheral area of the prostate | Procedure: Irreversible Electroporation<br> <br> * Other names: Nanoknife;|
| Active Comparator: More central ablation<br>an ablation, more centrally, in proximity of the urethra | Procedure: Irreversible Electroporation<br> <br> * Other names: Nanoknife;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety IRE ablation procedure | To determine if the IRE ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma. | 1 year | 
| Efficacy | To determine if complete ablation of the specified targeted ablation zone is achieved as measured by histopathology assessment. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | To determine if procedural side effects associated with current treatments for prostate cancer, mainly incontinence, erectile dysfunction and bowel damage are avoided as measured by the validated prostate cancer scores -EPIC, IIEF-5 and IPSS or time of CAD required. b) To determine patient satisfaction and comfort measured by Patient Satisfaction Questionnaire, post procedural pain management and pain score, time to ambulation, length of hospital stay. c) To determine accurateness of ablation zone detection by MRI/CEUS. | 1 year | 
| Quality of Life | To determine patient satisfaction and comfort measured by Patient Satisfaction Questionnaire, post procedural pain management and pain score, time to ambulation, length of hospital stay. | 1 year | 
| Ablation Zone Detection | To determine accurateness of ablation zone detection by MRI/CEUS | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focal therapy, irreversible electroporation, prostate cancer