Efficacy and Safety Assessment of IRE of Localized Prostate Cancer

Sponsor

I.M. Sechenov First Moscow State Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04192890

Collaborator

(none)

Enrollment

Location

Arm

22.1

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Adenocarcinoma	Device: Focal irreversible electroporation of the prostate cancer	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 27, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Urology and Reproductive Health, Sechenov University.	Moscow		Russian Federation	119991

Sponsors and Collaborators

I.M. Sechenov First Moscow State Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dmitry Enikeev, MD, PhD, Deputy Director for Research, I.M. Sechenov First Moscow State Medical University

ClinicalTrials.gov Identifier:

NCT04192890

Other Study ID Numbers:

Sechenov-IRE19

First Posted:

Dec 10, 2019

Last Update Posted:

Jul 22, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Dmitry Enikeev, MD, PhD, Deputy Director for Research, I.M. Sechenov First Moscow State Medical University

Prostate

Irreversible Electroporation

Prostate Cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jul 22, 2021