RecruitingNot ApplicableNCT06451445

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

Sponsor

University Health Network, Toronto

Enrollment

100 participants

Start Date

May 16, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 50 Years

Inclusion Criteria12

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

Exclusion Criteria19

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
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)

Interventions

DEVICEIrreversible 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.