Actively Recruiting
A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer
Led by University Health Network, Toronto · Updated on 2025-12-11
100
Participants Needed
1
Research Sites
467 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged over 50 years
- Life expectancy of at least 10 years
- Histologically confirmed organ-confined prostate cancer, clinical stage 64 T2c
- PSA 64 15 ng/mL or PSA density < 0.15 ng/mL2 if PSA is > 15 ng/mL
- Gleason score of 3+4 or 4+3
- No extraprostatic extension or seminal vesicle invasion seen on mpMRI
- Physician can visualize prostate gland adequately on transrectal ultrasound during biopsy
- Has had transperineal or transrectal targeted prostate biopsy plus 10-14 core systematic biopsy confirming Gleason 7 in MRI target and no Gleason 65 7 outside target
- Has a visible lesion on mpMRI accessible to IRE treatment
- Willing and able to sign informed consent
- Able and willing to attend all scheduled follow-up visits
You will not qualify if you...
- Known allergy to pancuronium bromide, atricurium, or cisatricurium
- Unfit for anesthesia or contraindicated for listed paralysis agents
- Active urinary tract infection
- History of bladder neck contracture
- Interested in future fertility
- History of inflammatory bowel disease within past 3 years
- Major debilitating illness
- Active treatment for any malignancy within past 3 years except prostate or certain skin cancers
- Has active implanted electronic devices (e.g., pacemaker)
- Unable or unwilling to perform catheterization
- Prior or current prostate cancer therapies including biologic, chemotherapy, hormonal (within 3 months), radiotherapy, or surgery
- Prior prostate stricture surgery, urethral stent, or prostate implants
- Prior major rectal surgery except hemorrhoids
- Unfit for pelvic MRI scanning due to claustrophobia, pacemaker, metallic implants causing artifacts, or allergy to gadolinium
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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