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

Prior treatment

• 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 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)

Other illness

• Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
• Has an active urinary tract infection (UTI)
• Has a history of bladder neck contracture
• Has a history (within 3 years) of inflammatory bowel disease
• 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)

Other

• Is unfit for anesthesia or has a contraindication for agents listed for paralysis
• Is interested in future fertility
• Has any active implanted electronic device (e.g., pacemaker)
• Is unable or unwilling to catheterize

• 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