NCT05512663

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

A Pilot Study Evaluating Safety and Efficacy of Transperineal Focal Irreversible Electroporation (IRE) of Anterior Prostate Cancer in Patients With an Intermediate Risk.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Jewish General Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There are different effective treatment options for intermediate risk prostate cancer to choose from. The standard of care are definite treatments such as robotic surgery or radiotherapy. Robotic surgeries involve the removal of the entire prostate. On the other hand, radiotherapy is a form of treatment that is done by either an external beam at high and low dose rate or by brachytherapy. The external beam at high or low dose rate targets the entire prostate. Brachytherapy, which involves a special radiation source that is placed inside the tumour, targets only specific parts of the prostate. Both robotic surgeries and radiotherapy provide a greater certainty of cancer control than any other treatments option, however there is a significant risk of side effects that many follow these treatments. Among which, there is a 50% likelihood for impotence, 5-10% likelihood of incontinence and 5-20% likelihood of bowel dysfunction. One way of reducing the unwanted side-effects from radical treatment of prostate cancer may be to direct treatment to only areas of the cancer. This is called focal therapy, which is the form of treatment that will be performed and observed in this study. There has been recent research done on focal therapies that have been shown to be more advantageous than having radical therapy or radiotherapy. Some of these advantages include: decrease of chance or elimination of possible side-effects post-treatment, it is a less invasive treatment option and the omission of overnight hospital stay post-treatment, among others. This study is designed to look at an experimental treatment of localized prostate cancer by Focal Irreversible Electroporation (IRE) delivered by the NanoKnife System.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-08-23
• Last updated: 2022-08-23

Regulatory

• FDA-regulated device study