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Safety and Efficacy Evaluation of Transperineal Irreversible Electroporation (IRE) of Anterior Prostate Cancer

NCT05512663 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-08-23

No results posted yet for this study

Summary

Most prostate cancer treatment research in the last decade has been focused on trying to improve quality of life, while maintaining a high level of cancer control. However, the concept of Focal treatment is proposed as an intermediate option between active surveillance and treatment of the whole prostate. Focal ablation aims to efficiently treat the localized cancer while reducing complications related to standard treatments, including the risks of incontinence and impotence.

Focal Irreversible Electroporation (IRE) delivered by NanoKnife System is composed of the NanoKnife Generator and NanoKnife Single Electrode Probes. With IRE, an electrical current is delivered between a pair of probes in a series of pulses. These pulses create irreversible pores in cell membranes and lead to cell death which allow for only the tissue between these probes being destroyed.

The aim of this study is to analyze the safety and efficacy of transperineal IRE treatments in intermediate risk anteriorly localized prostate cancer patients.

Conditions

Interventions

DEVICE

Irreversible Electroporation (IRE)

The area of the prostate that was positive for cancer based on the transperineal prostate biopsy will be targeted for ablation via the NanoKnife System. An MRI/TRUS fusion device probe will be placed in the rectum and the prostate will be visualized in both sagittal and axial views. The ultrasound grid which was used during the mapping biopsy will be oriented using anatomical landmarks and used to identify the location of the positive biopsy cores. The NanoKnife Single Electrode Probes will be surgically inserted into the prostate through the perineum using MRI/TRUS fusion guidance and the ultrasound grid for guidance.

Sponsors & Collaborators

  • Jewish General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512663 on ClinicalTrials.gov