Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.

July 27, 2020 updated by: Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University

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

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Clinic of Urology, Sechenov University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 months, 6 months, 9 months, 12 months.
Stable decrese of PSA level after surgery (<1 ng/ml)
3 months, 6 months, 9 months, 12 months.
Complications
Time Frame: 1 year
Short and long term surgical complications
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Study Director: Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medcal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sechenov-IRE18

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Focal irreversible electroporation of the prostate cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe