Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer

Study Overview
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Brief Summary
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Multi-centre Randomized Clinical Trial: 106 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study. Group 1: Focal ablation of the prostate at the side of the positive biopsies (focal-ablation) Group 2: Extended ablation of the prostate (extended ablation) Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. 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 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.

Official Title
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Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Irreversible Electroporation (Nanoknife)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Histologically confirmed organ-confined unilateral prostate cancer with adjacent positive biopsies on transperineal template prostate biopsies or MRI targeted biopsies in combination with systematic biopsies (clinical stage T1c-T2b) Gleason sum score 6 or 7 PSA <15 ng/ml or PSA > 15 ng/mL counselled with caution Life expectancy of > 10 years Exclusion Criteria Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/uL No ability to stop anticoagulant or anti-platelet therapy for 7 days prior the procedure. 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 except for basal cell carcinoma of the skin Cardiac history including arrhythmias, ICD or pacemaker Prostate calcifications greater than 5 mm. Biologic or chemotherapy for prostate cancer Hormonal therapy for prostate cancer within 6 months prior to procedure Previous radiation to pelvis Transurethral resection of the prostate / Urethral stent Prior major rectal surgery (except haemorrhoids)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Focal ablation<br>Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE | Device: Irreversible Electroporation (Nanoknife)<br> <br> * Other names: Nanoknife;|
| Active Comparator: Extended ablation<br>Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE | Device: Irreversible Electroporation (Nanoknife)<br> <br> * Other names: Nanoknife;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer | To determine post procedural side-effects and Quality of life measured by International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological efficacy IRE ablation of prostate cancer. | To determine if IRE focal ablation procedure is as effective as extended ablation measured by PSA, standardised transrectal biopsies and MRI findings in follow-up. To determine accurateness of ablation zone detection by MRI. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Focal therapy, Irreversible electroporation, Unilateral prostate cancer