Efficacy and Safety Assessment of IRE of Localized Prostate Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Adenocarcinoma
• Intervention / Treatment: Device: Focal irreversible electroporation of the prostate cancer

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).

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Institute for Urology and Reproductive Health, Sechenov University.
    • Contact: Dmitry Enikeev, MD; Phone Number: +7 925 517 79 26; Email: enikeev-dv@1msmu.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 8, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Prostate Cancer; Prostate; Irreversible Electroporation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Sechenov-IRE19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes