NCT03504995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

April 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

April 12, 2018

Last Update Submit

July 27, 2020

Conditions

Prostate CancerProstate Adenocarcinoma

Keywords

ProstateIrreversible ElectroporationProstate Cancer

Outcome Measures

Primary Outcomes (2)

  • PSA level

    Stable decrese of PSA level after surgery (\<1 ng/ml)

    3 months, 6 months, 9 months, 12 months.

  • Complications

    Short and long term surgical complications

    1 year

Secondary Outcomes (4)

  • IPSS (International Prostate Symptom Score, range from 5 to 30)

    1 year

  • QoL (Quality of Life score, range 1-6)

    1 year

  • Qmax

    1 year

  • IIEF

    1 year

Study Arms (1)

IRE patients

EXPERIMENTAL

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

Device: Focal irreversible electroporation of the prostate cancer

Interventions

Focal irreversible electroporation of the prostate cancerDEVICE

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

IRE patients

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Urology, Sechenov University

Moscow, 119991, Russia

Location

Related Publications (2)

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

    PMID: 17668932BACKGROUND

  • 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.

    PMID: 29594551BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Dmitry Enikeev, MD, PhD

    I.M. Sechenov First Moscow State Medcal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director for Science of RI of Uronephrology and Reproductive Health

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 20, 2018

Study Start

April 19, 2018

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

RU(1)