Efficacy and Safety Assessment of IRE of Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer. Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

Detailed Description
-----------------
Detailed Description: Irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant. Moreover, animal studies of IRE in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. The reason is that collagen matrix during treatment with IRE is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally. This study is a prospective and non-randomized with one group of 12 patients eligible for focal therapy of prostate cancer with IRE (eligibility defined by this protocol). Before the surgery all patients will underwent transperineal MRI-fusion biopsy to localize the prostate cancer foci. Objectives of the study: to asses safety of IRE in patients with localized PCa, to asses short-term oncologic efficacy of IRE in patients with localized PCa, to asses functional outcomes after IRE. All patients will be followed up for 1 year (each 3 months).

Official Title
-----------------
Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer

Conditions
-----------------
Prostate Cancer, Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Device: Focal irreversible electroporation of the prostate cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Verified with MR-fusion biopsy localized Pca PSA < 20 ng/ml Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2 Life expectancy > 10 years No post-void residual urine or infravesical obstruction Exclusion Criteria: patients with artificial cardiac pacemaker patients not eligible for general anesthesia patients after primary Pca treatment hormonal therapy six months before the study radiotherapy of pelvic organs urinary infection extracapsular Pca patients with metastatic lesions

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRE patients<br>patients who will underwent 'Focal irreversible electroporation of the prostate cancer' | Device: Focal irreversible electroporation of the prostate cancer<br>* Irreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA level | Stable decrease of PSA level after surgery (<1 ng/ml) | 3 months, 6 months, 9 months, 12 months | 
| Complications | Short and long term surgical complications according to Clavien-Dindo | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS (International Prostate Symptom Score, range from 5 to 30 | International Prostate Symptom Score | 1 year | 
| QoL (Quality of Life score, range 1-6) | Quality of Life Score | 1 year | 
| Qmax | Maximal urine flow rate | 1 year | 
| IIEF | International Index of Erectile Function - Erectile function assessment (range 1-5) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Irreversible Electroporation, Prostate Cancer