Prostate CancerWIREDNCT06451445
A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer
A study testing Irreversible Electroporation (NanoKnife) in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Irreversible Electroporation (NanoKnife)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2024to May 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Chemotherapy for prostate cancer
- Hormonal therapy for prostate cancer within three months of procedure
- Radiotherapy 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)
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4
Nathan Perlis, MD, 437-533-0228, nathan.perlis@uhn.ca
About this study
Official title: 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:
- Is the NanoKnife system is effective at damaging prostate tumour cells, and killing the cancer?
- 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.
Read the detailed description
Study Population This study is being conducted with intermediate-risk prostate cancer patients (Gleason score 7). This patient population was chosen because they would otherwise be treated with conventional therapies (RP or RT) which are often associated with significant side effects.
Study Design This study is designed to be a prospective, non-randomized study in 100 subjects treated at up to 5 clinical sites in Canada.
Prospective study subjects who sign a written informed consent will be enrolled in the study. Study eligibility will be confirmed at the Screening visit. Transperineal or transrectal prostate biopsy must have been performed no more than 180 days prior to the time of consent. mpMRI must have been within 360 days prior to treatment. If they continue to meet enrollment criteria, they will be scheduled for treatment and after undergoing standard bowel preparation, the NanoKnife System procedure will be carried out under general anesthesia and utilizing transrectal ultrasound (US) guidance.
Subjects will undergo treatment with the NanoKnife System as well as follow-up visits at 1, 3, 6, 9, and 12 months post-procedure. Transrectal US and transperineal or transrectal biopsy will be completed at the 12-month follow up visit. Post-treatment imaging will be completed using mpMRI scan at 9-12 months post-procedure.
Study Agent/ Intervention/ Procedure The intervention being studied is Irreversible Electroporation (IRE) using NanoKnife technology. This technology uses high voltage current 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.
Primary Objectives
- To determine the NanoKnife System's ablation effectiveness and durability by measuring the negative in-field biopsy rate at 12 months.
- To determine the NanoKnife System's procedural and post-procedural safety profile by evaluating adverse event incidence, type, and severity through 12 months.
Secondary Objectives
- To evaluate whether clinically significant prostate cancer will develop outside the ablation zone in men selected for focal IRE therapy as determined by positive prostate biopsy outside the ablation zone 12 months post treatment.
- To evaluate urinary and erectile function after NanoKnife System treatment using validated subject questionnaires (UCLA-EPIC, IPSS, IPSS-QOL, IIEF-15).
- To determine post-NanoKnife System treatment prostate-specific antigen (PSA) kinetics, including time to PSA nadir and post-nadir PSA stability.
- To determine the effectiveness of therapy by assessing the need for secondary or salvage treatment following therapy.
- To determine health-related quality of life (HRQoL) levels after treatment with the NanoKnife System using a validated subject questionnaire (EQ-5D).
Exploratory Objective
- To evaluate longer term effectiveness of focal IRE and possible delayed adverse events through 5-years.
- Conditions
- Prostate Cancer
- Being tested
- Irreversible Electroporation (NanoKnife)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible Electroporation (NanoKnife)Device
Also called NanoKnife System
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.
| Study group | Role | What they receive |
|---|---|---|
| IRE Treatment Arm | Experimental | All patients enrolled in this trial will receive IRE treatment with the NanoKnife System. Receives: Device: Irreversible Electroporation (NanoKnife) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of negative in-field biopsy at 12 months
To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months
Measured: 1 year
Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
To determine the NanoKnife System's procedural and post-procedural safety profile by evaluation adverse event incidence, type, and severity through 12 months
Measured: 1 year
Secondary outcomes (6)
Evaluation of clinically significant prostate cancer rate of development outside the ablation zone
To evaluate whether clinically significant prostate cancer will develop outside the ablation zone in men selected for focal IRE therapy as determined by positive prostate biopsy outside the ablation zone 12 months post treatment
Measured: 1 year
Assessment of urinary function after NanoKnife System treatment by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite
Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain and International Prostate Symptom Scores (IPSS) and IPSS Quality of Life2 (IPSS-QoL) scores.
Measured: 1 year
Assessment of erectile function after NanoKnife System treatment by comparison of pre- and post-operative IIEF-15 potency scores
Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores.
Measured: 1 year
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics
To determine post-NanoKnife System treatment prostate-specific antigen (PSA) kinetics, including time to PSA nadir and post-nadir PSA stability
Measured: 1 year
Assessment of need for secondary or adjuvant treatment
To determine the effectiveness of therapy by collecting data on the number of patients who need secondary or adjuvant treatment within 12-months post-procedure
Measured: 1 year
Evaluation of subject reported pre- and post-operative Quality of Life
To determine health-related quality of life (HRQoL) levels after treatment with the NanoKnife System using a validated subject questionnaire (EQ-5D)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start16 May 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451445
- Sponsor's protocol ID
- 23-5926
- Acronym
- WIRED
- Status last verified
- Jun 2026
- First submitted
- 29 May 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer: The WIRED Study
- ClinicalTrials.gov ID
- NCT06451445
- Acronym / sponsor ID
- WIRED / 23-5926
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the NanoKnife system is effective at damaging prostate tumour cells, and killing the cancer?
- 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.
Detailed description
Study Population This study is being conducted with intermediate-risk prostate cancer patients (Gleason score 7). This patient population was chosen because they would otherwise be treated with conventional therapies (RP or RT) which are often associated with significant side effects.
Study Design This study is designed to be a prospective, non-randomized study in 100 subjects treated at up to 5 clinical sites in Canada.
Prospective study subjects who sign a written informed consent will be enrolled in the study. Study eligibility will be confirmed at the Screening visit. Transperineal or transrectal prostate biopsy must have been performed no more than 180 days prior to the time of consent. mpMRI must have been within 360 days prior to treatment. If they continue to meet enrollment criteria, they will be scheduled for treatment and after undergoing standard bowel preparation, the NanoKnife System procedure will be carried out under general anesthesia and utilizing transrectal ultrasound (US) guidance.
Subjects will undergo treatment with the NanoKnife System as well as follow-up visits at 1, 3, 6, 9, and 12 months post-procedure. Transrectal US and transperineal or transrectal biopsy will be completed at the 12-month follow up visit. Post-treatment imaging will be completed using mpMRI scan at 9-12 months post-procedure.
Study Agent/ Intervention/ Procedure The intervention being studied is Irreversible Electroporation (IRE) using NanoKnife technology. This technology uses high voltage current 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.
Primary Objectives
- To determine the NanoKnife System's ablation effectiveness and durability by measuring the negative in-field biopsy rate at 12 months.
- To determine the NanoKnife System's procedural and post-procedural safety profile by evaluating adverse event incidence, type, and severity through 12 months.
Secondary Objectives
- To evaluate whether clinically significant prostate cancer will develop outside the ablation zone in men selected for focal IRE therapy as determined by positive prostate biopsy outside the ablation zone 12 months post treatment.
- To evaluate urinary and erectile function after NanoKnife System treatment using validated subject questionnaires (UCLA-EPIC, IPSS, IPSS-QOL, IIEF-15).
- To determine post-NanoKnife System treatment prostate-specific antigen (PSA) kinetics, including time to PSA nadir and post-nadir PSA stability.
- To determine the effectiveness of therapy by assessing the need for secondary or salvage treatment following therapy.
- To determine health-related quality of life (HRQoL) levels after treatment with the NanoKnife System using a validated subject questionnaire (EQ-5D).
Exploratory Objective
- To evaluate longer term effectiveness of focal IRE and possible delayed adverse events through 5-years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRE Treatment Arm | Experimental | Device: Irreversible Electroporation (NanoKnife)All patients enrolled in this trial will receive IRE treatment with the NanoKnife System. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible Electroporation (NanoKnife)Also: NanoKnife SystemIrreversible 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. | Device | IRE Treatment Arm |
Primary outcome
Rate of negative in-field biopsy at 12 months
Time frame: 1 year
To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months
Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
Time frame: 1 year
To determine the NanoKnife System's procedural and post-procedural safety profile by evaluation adverse event incidence, type, and severity through 12 months
6 secondary outcomes
Evaluation of clinically significant prostate cancer rate of development outside the ablation zone
Time frame: 1 year
Assessment of urinary function after NanoKnife System treatment by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite
Time frame: 1 year
Assessment of erectile function after NanoKnife System treatment by comparison of pre- and post-operative IIEF-15 potency scores
Time frame: 1 year
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics
Time frame: 1 year
Assessment of need for secondary or adjuvant treatment
Time frame: 1 year
Evaluation of subject reported pre- and post-operative Quality of Life
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible Electroporation (NanoKnife) in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of negative in-field biopsy at 12 months (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.