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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorUniversity Health Network, Toronto

About this trial

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 criteria

Qualifiers

Is greater than 50 years of age

Has at least a 10-year life expectancy

Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c

Has a PSA ≤ 15 ng/mL or PSA density < 0.15 ng/mL2 if PSA is > 15 ng/mL

Disqualifiers

Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium

Is unfit for anesthesia or has a contraindication for agents listed for paralysis

Has an active urinary tract infection (UTI)

Has a history of bladder neck contracture

Trial design

Treatments tested in this trial

  • Irreversible Electroporation (NanoKnife)

Treatment groups

100 Participants
are divided into 1 treatment group