A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer: The WIRED Study
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.
• 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
• Has Gleason score 3+4 or 4+3
• Has no evidence of extraprostatic extension by mpMRI
• Has no evidence of seminal vesicle invasion by mpMRI
• Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during qualifying biopsy
• Has a transperineal or transrectal targeted prostate biopsy of MRI-visible lesions, plus 10-14 core systematic biopsy confirming Gleason = 7 in MRI target and absence of Gleason ≥ 7 outside target
⁃ A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment \[Note: prostate cancer detected via systematic standard biopsy outside of the adjacent sextant location of the MRI visible lesion will meet entry criterion provided the positive core is Gleason 6; has fewer than 3 prostate biopsy fragments/cores positive\]
⁃ Willing and able to sign a written informed consent form.
⁃ Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits