A Pan-Canadian, Investigator Initiated Clinical Trial With Focal IRE Directed to Intermediate-Risk Prostate Cancer
Recruiting · NCT06451445 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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)
Where it is running
1 location listed.
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada