Ensayos clínicos

Inclusion Criteria:

1. Is greater than 50 years of age

2. Has at least a 10-year life expectancy

3. Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c

4. Has a PSA ≤ 15 ng/mL or PSA density < 0.2 ng/mL2 if PSA is > 15 ng/mL

5. Has Gleason score 3+4 or 4+3

6. Has no evidence of extraprostatic extension by mpMRI

7. Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by
biopsy

8. Physician is able to visualize prostate gland adequately on transrectal ultrasound
imaging during enrollment evaluation

9. Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 core
systematic biopsies to include adequate sampling of the peripheral zone correlating
with an intermediate risk lesion in the area of the MR-visible lesion

10. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE)
treatment (Note: A non-MRI visible lesion detected via systematic standard biopsy will
not be considered an exclusion criterion provided the non-MRI visible lesion is
singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and
comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core
on standard biopsy)

11. Has signed a written informed consent and in the judgment of the physician, the study
is in the best interest of the subject

12. Understands and accepts the obligation and is logistically able to present for all
scheduled follow-up visits

Exclusion Criteria:

1. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium

2. Is unfit for anesthesia or has a contraindication for agents listed for paralysis

3. Has an active urinary tract infection (UTI)

4. Has a history of bladder neck contracture

5. Is interested in future fertility

6. Has a history (within 3 years) of inflammatory bowel disease

7. Has a concurrent major debilitating illness

8. Had active treatment for a malignancy within 3 years, including malignant melanoma,
except for prostate cancer or other types of skin cancer

9. Has any active implanted electronic device (e.g., pacemaker)

10. Is unable to catheterize due to a urethral stricture disease

11. Has 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. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or
prostatic implants

13. Has had prior major rectal surgery (except hemorrhoids)

14. 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))

15. Is actively bleeding, is anticoagulated or on blood thinning medications, or has a
bleeding disorder

16. Is a member of a vulnerable population such as prisoners, handicapped or mentally
disabled persons, or economically or educationally disadvantaged persons

17. In the opinion of the treating physician, has a contraindication listed in the current
NanoKnife System User Manual (section 2.3)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/16/23. Questions regarding updates should be directed to the study team contact.