Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.

Not Applicable

Completed

• Conditions: Prostate Adenocarcinoma; Prostate Cancer
• Interventions: Device: Focal irreversible electroporation of the prostate cancer

• Registration Number: NCT03504995
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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).

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study Start: 2018-04-19
• Study First Posted: 2018-04-20
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRE patients	Focal irreversible electroporation of the prostate cancer	patients who will underwent 'Focal irreversible electroporation of the prostate cancer'

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Clinic of Urology, Sechenov University; 🇷🇺 Moscow, Russian Federation