Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population

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The purpose of this study is to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue when used in an intermediate-risk patient population. This study will involve 118 subjects in the US who meet the intermediate-risk criteria defined by this protocol. The subjects' prostate lesions, the locations of which will be determined by ultrasound-guided transperineal or transrectal prostate biopsy, will be targeted for treatment with the NanoKnife System. The primary objective of this the study will be to evaluate the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months, and the procedural and post-treatment safety of the NanoKnife System via incidence and severity of adverse events through 12 months. The secondary objective of this study is to evaluate urinary and erectile function after NanoKnife System treatment using validated subject questionnaires, and to evaluate pre- and post-treatment changes in PSA and prostate volume. Other secondary outcomes include the effectiveness of the NanoKnife System by assessing the need for secondary or adjuvant treatment and health-related quality of life evaluated using validated subject questionnaires. This group of subjects will be followed for safety and efficacy for 12 months, which includes follow-up checks. During this time, subjects will receive treatment with the NanoKnife and then standard of care treatment for prostate cancer. In this study, blood and urine samples will be collected for safety tests. During the study, the amount of blood drawn will be within the standard accepted guidelines for research purposes. In addition, an MRI and/or ultrasound exam will be performed at some visits, and subjects will undergo a follow-up prostate biopsy at Visit 8 (twelve months), or if a recurrence of cancer is suspected. The sponsor will have access to subject medical records for up to four years after their participation in the study is complete, in order to continue to study the long-term effects of the NanoKnife treatment.




Inclusion Criteria A subject is required to fulfill all the following criteria to be included in the study: 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 < 0.15 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 10-14 core systematic biopsies to include adequate sampling of the peripheral zone correlating with an intermediate risk lesion1 in the area of the MR-visible lesion 10. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment (Note: If prostate cancer is detected via systematic standard biopsy outside of the MRI visible lesion it will not be considered an exclusion criterion provided the positive core 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 A subject will be excluded from participation in the study if they meet any of the following 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 (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) 9. Has any active implanted electronic device (e.g., pacemaker) 10. Is unable or unwilling to catheterize 11. Has had prior or current prostate cancer therapies: a) Biologic therapy for prostate cancer b) Chemotherapy for prostate cancer c) Hormonal therapy for prostate cancer within three months of procedure d) Radiotherapy for prostate cancer e) 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

Type of Study

Device Feasibility


Lone Tree Medical Center
University of Colorado Hospital

Principal Investigator
Photograph of Al Baha Barqawi,  MD

Al Baha Barqawi, MD

Study ID

Protocol Number: 21-2798

More information available at ClinicalTrials.gov: NCT04972097

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