NCT04192890

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

December 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.8 years

First QC Date

December 8, 2019

Last Update Submit

July 21, 2021

Conditions

Prostate CancerProstate Adenocarcinoma

Keywords

ProstateIrreversible ElectroporationProstate Cancer

Outcome Measures

Primary Outcomes (2)

  • PSA level

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

    3 months, 6 months, 9 months, 12 months

  • Complications

    Short and long term surgical complications according to Clavien-Dindo

    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

Age40 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPresence of the prostate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

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 Research

Study Record Dates

First Submitted

December 8, 2019

First Posted

December 10, 2019

Study Start

January 27, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

RU(1)