Ensayos clínicos

Inclusion Criteria:

Subjects are required to fulfill all the following criteria to be included in the study:

• Has at least a 10 year life expectancy.
• Have histologically confirmed organ-confined prostate cancer - clinical Stage T1 or T2a.
• Have a PSA less than 10 ng/mL.
• Has Gleason score 3+3 or 3+4/4+3.
• Has 10 mm or less of cancer in any biopsy core.
• No evidence of extraprostatic extension or seminal vesicle invasion by mpMRI.
• Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation.
• Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with low to intermediate risk lesion1 in the area of the MR-visible lesion (within 2 Barzell zones).
• An visible lesion on mpMRI, that is accessible to IRE treatment.
• Must sign a written informed consent.
• Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits.

Exclusion Criteria:

Subjects will be excluded from participation in the study if they meet any of the following:

• Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium.
• Unfit for anthesthia or have a contraindication for agents listed for paralysis.
• Have an active urinary tract infection (UTI).
• Have a history of bladder neck contracture.
• Are interested in future fertility.
• Have a history (within 3 years) of inflammatory bowel disease.
• Have a concurrent major debilitating illness.
• Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years.
• Have any active implanted electronic device (e.g., pacemaker).
• Are unable to catheterize due to a urethral stricture disease.
• Have had prior or current prostate cancer therapies:
  • 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.
• Have had prior transurethral prostatectomy (TURP), or urethral stent.
• Have had prior major rectal surgery (except hemorrhoids).
• Unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implant etc… likely to contribute significant artefact to images).
• Have a prior diagnosis of prostate cancer.
• Have a non-visible tumor on mpMRI.