Using NanoKnife technology to treat intermediate-risk prostate cancer
A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer: The WIRED Study
This study is testing if a new treatment using NanoKnife technology can safely target and damage tumor cells in men with intermediate-risk prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06451445 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of Irreversible Electroporation (IRE) using NanoKnife technology in patients with intermediate-risk prostate cancer. The study aims to determine if the NanoKnife system effectively damages prostate tumor cells and whether there are any significant safety concerns associated with the procedure. Participants will receive IRE treatment and will be monitored through follow-up appointments for 12 months to assess treatment outcomes and side effects. The study involves a prospective, non-randomized design with 100 subjects across multiple clinical sites in Canada.
Who should consider this trial
Good fit: Ideal candidates for this study are men over 50 years old with histologically confirmed organ-confined prostate cancer and a Gleason score of 7.
Not a fit: Patients with advanced prostate cancer or those with significant comorbidities that limit life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients with intermediate-risk prostate cancer, potentially reducing side effects compared to conventional therapies.
How similar studies have performed: While the use of NanoKnife technology is relatively novel in this context, similar studies exploring IRE for cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Is greater than 50 years of age
2. Has at least a 10-year life expectancy
3. Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
4. Has a PSA ≤ 15 ng/mL or PSA density \< 0.15 ng/mL2 if PSA is \> 15 ng/mL
5. Has Gleason score 3+4 or 4+3
6. Has no evidence of extraprostatic extension by mpMRI
7. Has no evidence of seminal vesicle invasion by mpMRI
8. Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during qualifying biopsy
9. 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
10. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment \[Note: prostate cancer detected via systematic standard biopsy outside of the adjacent sextant location of the MRI visible lesion will meet entry criterion provided the positive core is Gleason 6; has fewer than 3 prostate biopsy fragments/cores positive\]
11. Willing and able to sign a written informed consent form.
12. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
Exclusion Criteria:
1. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
2. Is unfit for anesthesia or has a contraindication for agents listed for paralysis
3. Has an active urinary tract infection (UTI)
4. Has a history of bladder neck contracture
5. Is interested in future fertility
6. Has a history (within 3 years) of inflammatory bowel disease
7. Has a concurrent major debilitating illness
8. 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)
9. Has any active implanted electronic device (e.g., pacemaker)
10. Is unable or unwilling to catheterize
11. Has had any prior or current prostate cancer therapy, including:
1. Biologic therapy for prostate cancer
2. Chemotherapy for prostate cancer
3. Hormonal therapy for prostate cancer within three months of procedure
4. Radiotherapy for prostate cancer
5. Surgery for prostate cancer
12. Has had prior prostate stricture surgery, urethral stent or prostatic implants
13. Has had prior major rectal surgery (except hemorrhoids)
14. 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)
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.