Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.

Prostate Cancer Clinical Trial

Official title:

Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504995
• Other study ID #: Sechenov-IRE18
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2020
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Clinic of Urology, Sechenov University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. — View Citation

Scheltema MJ, Chang JI, Böhm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA level	Stable decrese of PSA level after surgery (<1 ng/ml)	3 months, 6 months, 9 months, 12 months.
Primary	Complications	Short and long term surgical complications	1 year
Secondary	IPSS (International Prostate Symptom Score, range from 5 to 30)	International Prostate Symptom Score	1 year
Secondary	QoL (Quality of Life score, range 1-6)	Quality of Life Score	1 year
Secondary	Qmax	Maximal urine flow rate	1 year
Secondary	IIEF	International Index of Erectile Function - Erectile function assessment (range 1-5)	1 year