NCT04192890

Efficacy and Safety Assessment of IRE of Localized Prostate Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

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 12 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).

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-27
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-12-10
• Last updated: 2021-07-22

Locations

1 site across 1 country: Russia

Regulatory

• FDA-regulated device study