Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.
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|ClinicalTrials.gov Identifier: NCT03504995|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : August 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Adenocarcinoma||Device: Focal irreversible electroporation of the prostate cancer||Not Applicable|
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 10 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer.|
|Actual Study Start Date :||April 19, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: IRE patients
patients who will underwent 'Focal irreversible electroporation of the prostate cancer'
Device: Focal irreversible electroporation of the prostate cancer
Irreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane.
- PSA level [ Time Frame: 3 months, 6 months, 9 months, 12 months. ]Stable decrese of PSA level after surgery (<1 ng/ml)
- Complications [ Time Frame: 1 year ]Short and long term surgical complications
- IPSS (International Prostate Symptom Score, range from 5 to 30) [ Time Frame: 1 year ]International Prostate Symptom Score
- QoL (Quality of Life score, range 1-6) [ Time Frame: 1 year ]Quality of Life Score
- Qmax [ Time Frame: 1 year ]Maximal urine flow rate
- IIEF [ Time Frame: 1 year ]International Index of Erectile Function - Erectile function assessment (range 1-5)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504995
|Contact: Dmitry Enikeev, MD, PhD||+7 925 517 79 firstname.lastname@example.org|
|Clinic of Urology, Sechenov University||Recruiting|
|Moscow, Russian Federation, 119991|
|Contact: Dmitry Enikeev, MD, PhD +7 925 517 79 26 email@example.com|
|Study Director:||Dmitry Enikeev, MD, PhD||I.M. Sechenov First Moscow State Medcal University|