Efficacy and Safety Assessment of IRE of Localized Prostate Cancer

NCT ID: NCT04192890

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2021-12-01

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).

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IRE patients

patients who will underwent 'Focal irreversible electroporation of the prostate cancer'

Group Type: EXPERIMENTAL

Focal irreversible electroporation of the prostate cancer

Intervention Type: DEVICE

Irreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dmitry Enikeev, MD, PhD

Deputy Director for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Facility Contacts

Dmitry Enikeev, MD

Role: primary

enikeev-dv@1msmu.ru

+7 925 517 79 26

Other Identifiers

Sechenov-IRE19

Identifier Type: -

Identifier Source: org_study_id