RecruitingNot ApplicableNCT06451445

A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer

A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer: The WIRED Study

Sponsor

University Health Network, Toronto

Enrollment

100 participants

Start Date

May 16, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

The goal of this clinical trial is to investigate the safety and efficacy of Irreversible Electroporation (IRE) using NanoKnife technology in patients with intermediate-risk prostate cancer. This patient population was chosen because they would otherwise be treated with conventional therapies with high side effects. The main questions it aims to answer are: 1. Is the NanoKnife system is effective at damaging prostate tumour cells, and killing the cancer? 2. Are there any safety concerns with the procedure, or major side effects caused by the treatment? Participants will undergo IRE treatment with the NanoKnife system, and then complete follow-up appointments for 12-months after the procedure.

Eligibility

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This Canadian study tests a focal treatment for prostate cancer called Irreversible Electroporation (IRE), which uses electrical pulses to destroy only the cancer while preserving the rest of the prostate. This approach aims to reduce side effects like incontinence and sexual dysfunction compared to treating the whole gland. **You may be eligible if...** - You are over 50 years old with at least 10 years of life expectancy - You have intermediate-risk prostate cancer confirmed by biopsy (Gleason score 7, either 3+4 or 4+3) - Your cancer is confined to the prostate (no spread outside or into the seminal vesicles on MRI) - Your PSA level is 15 ng/mL or below (or meets specific density criteria) - Your cancer is visible on MRI and accessible for the IRE procedure **You may NOT be eligible if...** - Your cancer has spread outside the prostate - You have high-grade cancer (Gleason 8 or above) - You cannot have the procedure due to anatomical or health reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIrreversible Electroporation (NanoKnife)

Irreversible Electroporation (IRE) using NanoKnife technology uses high voltage current pulses via probes placed around the prostate tumour via the perineum. The electricity damages the cell membranes rendering the cells dead. Hypothesized benefits of IRE over other focal therapy options include the ability to treat large or small lesions. Also, because the technology spares vessels, it can be used to treat prostate areas adjacent to sensitive structures (ie prostate apex near the sphincter and lateral peripheral zone near the neurovascular bundle). Finally, treatments take approximately 1-1.5 hours, thus the technology could be used to treat several patients per day.