A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer

NCT06451445 | Recruiting

• 1 other identifier: 23-5926
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the NanoKnife system is effective at damaging prostate tumour cells, and killing the cancer?
2. 2.Are there any safety concerns with the procedure, or major side effects caused by the treatment?

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1 year

Secondary Outcomes (6)

• Evaluation of clinically significant prostate cancer rate of development outside the ablation zone

  1 year

• Assessment of urinary function after NanoKnife System treatment by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite

  1 year

• Assessment of erectile function after NanoKnife System treatment by comparison of pre- and post-operative IIEF-15 potency scores

  1 year

• Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics

  1 year

• Assessment of need for secondary or adjuvant treatment

  1 year

Other Outcomes (2)

• Evaluation of longer term effectiveness of focal IRE

  5 years

• Collection of data on possible delayed adverse events

  5 years

Study Arms (1)

IRE Treatment Arm

EXPERIMENTAL

All patients enrolled in this trial will receive IRE treatment with the NanoKnife System.

Device: Irreversible Electroporation (NanoKnife)

Interventions

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.

Also known as: NanoKnife System

IRE Treatment Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 11, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2033
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)