Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT01972867
Eligibility Criteria:
Inclusion Criteria:
1. Has at least a 10-year life expectancy
2. Have histologically confirmed organ-confined prostate cancer - clinical Stage ≤ T2c
3. Have a PSA ≤ 15 ng/mL or PSA density \< 0.15 ng/mL2 if PSA is \> 15 ng/mL
4. Has Gleason score 3+4 or 4+3
5. Has 10 mm or less of cancer-bearing prostate tissue in any biopsy core
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 targeted prostate biopsies of lesion, plus 12 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.
9. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment
10. A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6mm linear extent of cancer-bearing tissue in a single core on standard biopsy.
11. Must sign a written informed consent
12. 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 anesthesia 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 within 5 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
9. Have any active implanted electronic device (e.g., 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), stricture surgery, urethral stent or prostatic implants
13. Have had prior major rectal surgery (except hemorrhoids)
14. 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)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01972867
Study Brief:
Protocol Section:
NCT01972867