Testing Irreversible Electroporation (NanoKnife) for prostate cancer
Official title: 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
Interventions
Irreversible 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.
Canadian Sites (1)
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- +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
- +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 formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Understands and accepts the obligation and is logistically able to present for all scheduled follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits
Exclusion
- −Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
- −Is unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute significant image artifacts, allergy or contraindication to gadolinium (to enhance MRI)
- −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)
- −Has any active implanted electronic device (e.g., pacemaker)
- −Is unable or unwilling to catheterize
- −Has had any prior or current prostate cancer therapy, including:
- −Biologic therapy for prostate cancer
- −Hormonal therapy for prostate cancer within three months of procedure
- −Radiotherapy for prostate cancer
- −Chemotherapy for prostate cancer
- −Surgery for prostate cancer
- −Has had prior prostate stricture surgery, urethral stent or prostatic implants
- −Has had prior major rectal surgery (except hemorrhoids)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Irreversible Electroporation (NanoKnife).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 50 years, with no upper limit given.
The study lists male participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around May 2033.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Rate of negative in-field biopsy at 12 months — measured over 1 year.
Incidence of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → by type and CTCAE v5.0 severity through 12 months — measured over 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06451445 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Irreversible Electroporation (NanoKnife)Device
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 50 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 50 years, with no upper limit given.
It lists male participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2033-05.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.