Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.

NCT ID: NCT03504995

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2020-04-30

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

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).

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 < 15 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 without rectum
• patients not eligible for general anesthesia
• PIRADS<3
• 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: 18 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 Science of RI of Uronephrology and Reproductive Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dmitry Enikeev, MD, PhD

Role: STUDY_DIRECTOR

I.M. Sechenov First Moscow State Medcal University

Locations

Clinic of Urology, Sechenov University

Moscow, , Russia

Countries

Russia

References

Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.

Reference Type: BACKGROUND

PMID: 17668932 (View on PubMed)

Scheltema MJ, Chang JI, Bohm M, van den Bos W, Blazevski A, Gielchinsky I, Kalsbeek AMF, van Leeuwen PJ, Nguyen TV, de Reijke TM, Siriwardana AR, Thompson JE, de la Rosette JJ, Stricker PD. Pair-matched patient-reported quality of life and early oncological control following focal irreversible electroporation versus robot-assisted radical prostatectomy. World J Urol. 2018 Sep;36(9):1383-1389. doi: 10.1007/s00345-018-2281-z. Epub 2018 Mar 28.

Reference Type: BACKGROUND

PMID: 29594551 (View on PubMed)

Other Identifiers

Sechenov-IRE18

Identifier Type: -

Identifier Source: org_study_id