A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Ris… (NCT06451445) | Clinical Trial Compass
RecruitingNot Applicable
A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer
Canada100 participantsStarted 2024-05-16
Plain-language 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.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of negative in-field biopsy at 12 months
Timeframe: 1 year
2
Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
. 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
. Is interested in future fertility
. Has a history (within 3 years) of inflammatory bowel disease
. Has a concurrent major debilitating illness
. Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer (Note: subjects with untreated active concomitant cancers are excluded, only subjects deemed to be in remission by their cancer care provider for at least three years are eligible)