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Clinical Trial 21989

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT04972097

Phase: Phase II
Principal Investigator: Yu, Alice

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Study Title

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


Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.


Primary Objectives: 1. To determine the NanoKnife System s ablation effectiveness by measuring the negative in-field biopsy rate at 12 months. 2. To determine the NanoKnife System s procedural and post-procedural safety profile by evaluating adverse event incidence, type, and severity through 12 months. Secondary Objectives: 1. To evaluate urinary and erectile function after NanoKnife System treatment using validated subject questionnaires (UCLA-EPIC, IPSS, IPSS-QOL, IIEF-15). 2. To determine post-NanoKnife System treatment prostate-specific antigen (PSA) kinetics, including time to PSA nadir and post-nadir PSA stability. 3. To determine the change in prostate volume by comparison of prostate volume measured on multiparametric MRI (mpMRI) pre-treatment and at 12 months post-treatment. 4. To determine the effectiveness of therapy by assessing the need for secondary or adjuvant treatment following therapy. 5. To determine health-related quality of life (HRQoL) levels after treatment with the NanoKnife System using a validated subject questionnaire (EQ-5D).





Inclusion Criteria

Inclusion Criteria:

  • Over 50 years of age
  • Has at least a 10-year life expectancy
  • Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
  • Has a PSA ≤ 15 ng/mL or PSA density 15 ng/mL
  • Has Gleason score 3+4 or 4+3
  • Has no evidence of extraprostatic extension by mpMRI
  • Has 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
  • 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
  • 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)
  • Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject
  • Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits

  • Exclusion Criteria

    Exclusion Criteria:

  • Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
  • Is unfit for anesthesia or has a contraindication for agents listed for paralysis
  • Has an active urinary tract infection (UTI)
  • Has a history of bladder neck contracture
  • Is interested in future fertility
  • Has a history (within 3 years) of inflammatory bowel disease
  • Has a concurrent major debilitating illness
  • Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
  • Has any active implanted electronic device (e.g., pacemaker)
  • Is unable to catheterize due to a urethral stricture disease
  • Has 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
  • Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
  • Has had prior major rectal surgery (except hemorrhoids)
  • 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))
  • Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder
  • Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons
  • In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.