Clinical Trial TitleA study to evaluate the effectiveness and safety of the NanoKnife System for the ablation of Prostate Tissue: NanoKnife System for Ablation of Prostate Tissue in a Intermediate-Risk Patient Population: Pivotal Study
National Clinical Trial Number:NCT04972097
Clinical Trial Protocol Description:
The purpose of this study is to learn more about the use of the NanoKnife System for the treatment of early-stage prostate cancer.
This study will assess the safety and effectiveness of the device when used to remove prostate tissue in intermediate-risk prostate cancer patients. This study is being run for research purposes. The NanoKnife is a type of irreversible electroporation (IRE) device. “Electroporation” is a cellular destruction technology that can be used to treat cancer. It uses electrical pulses to make small holes in cells that result in cell death. The use of this device for the treatment of prostate cancer is not approved or cleared by the Food and Drug Administration (FDA), which means the use of the device in this study is investigational.
All subjects in this study will undergo treatment with the NanoKnife system and then receive “standard of care” for the further treatment of prostate cancer. The standard of care for further treatment of prostate cancer will be determined by the hospital where subject receives treatment.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are greater than 50 years of age.
- Havevat least a 10-year life expectancy.
- Have histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c.
- Have a PSA ≤ 15 ng/mL or PSA density < 0.15 ng/mL2if PSA is > 15 ng/mL.
- Have Gleason score 3+4 or 4+3.
- Have no evidence of extraprostatic extension by mpMRI.
- Have no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy.
- Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation.
- Have 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 lesion in the area of the MR-visible lesion.
- Have 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.)
- Have signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject.
- Understand and acceptsthe obligation and is logistically able to present for all scheduled follow-up visits.
You will be excluded from the study if any of the following criteria apply to you:
- Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium.
- Are unfit for anesthesia or has 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.
- Have 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.)
- Have any active implanted electronic device (e.g., pacemaker).
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.