Safety and Efficacy Evaluation of Transperineal Irreversible Electroporation (IRE) of Anterior Prostate Cancer

Launched by JEWISH GENERAL HOSPITAL · Aug 22, 2022

Keywords

ClinConnect Summary

There are different effective treatment options for intermediate risk prostate cancer to choose from. The standard of care are definite treatments such as robotic surgery or radiotherapy. Robotic surgeries involve the removal of the entire prostate. On the other hand, radiotherapy is a form of treatment that is done by either an external beam at high and low dose rate or by brachytherapy. The external beam at high or low dose rate targets the entire prostate. Brachytherapy, which involves a special radiation source that is placed inside the tumour, targets only specific parts of the prostat...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Has at least a 10 year life expectancy 2. Have histologically confirmed organ-confined prostate cancer - clinical Stage T1-T2c N0M0 3. Have a PSA \<=15ng/mL 4. Has Gleason \<=7 (4+3 or 3+4) 5. Has maximum cancer core length \>=4mm 6. No evidence of extraprostatic extension or seminal vesicle invasion by mpMRI 7. Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation 8. Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with clinically significant lesion in the area of the MR-visible lesion (within 2 Barzell zones) 9. A visible lesion on mpMRI, that is accessible to IRE treatment 10. Must sign a written informed consent 11. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
• Exclusion Criteria:
• * 1. Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium 2. Unfit for anthesthia or have a contraindication for agents listed for paralysis 3. Have an active urinary tract infection (UTI) 4. Have a history of bladder neck contracture 5. Are interested in future fertility 6. Have a history (within 3 years) of inflammatory bowel disease 7. Have a concurrent major debilitating illness 8. Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years 9. Have any active implanted electronic device (eg, pacemaker) 10. Are unable to catheterize due to a urethral stricture disease 11. Have had prior or current prostate cancer therapies:
• • 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. Have had prior transurethral prostatectomy (TURP), or urethral stent 13. Have had prior major rectal surgery (except hemorrhoids) 14. Unfit for pelvic MRI scanning (e.g. severe claustrophobia, permanent cardiac pacemaker, metallic implant etc... likely to contribute significant artefact to images) 15. Have a non-visible tumor on mpMRI