Clinical Trials /

Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk Patients

NCT01972867

Description:

The purpose of this study is to evaluate the feasibility and short-term safety and effectiveness of the NanoKnife System when used to ablate localized prostate cancer in intermediate risk subjects with organ-confined prostate cancer. This study will evaluate the feasibility of the NanoKnife System as a focal therapy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk Patients
  • Official Title: A Pilot Study in Human Subjects Evaluating the Use of the NanoKnife System for Ablation of Prostate Cancer Tissue in an Intermediate Risk Patient Population

Clinical Trial IDs

  • ORG STUDY ID: ON-NK310
  • NCT ID: NCT01972867

Conditions

  • Prostate Cancer

Purpose

The purpose of this study is to evaluate the feasibility and short-term safety and effectiveness of the NanoKnife System when used to ablate localized prostate cancer in intermediate risk subjects with organ-confined prostate cancer. This study will evaluate the feasibility of the NanoKnife System as a focal therapy.

Detailed Description

      This study will involve six (6) subjects who meet the intermediate risk prostate cancer
      criteria defined by this protocol. The biopsy and imaging techniques that we will adopt
      within this trial are multiparametric MRI (mpMRI) and transperineal prostate biopsy (template
      mapping and/or limited targeted). The subjects' prostate cancer foci, the location of which
      will be determined by ultrasound guided transperineal prostate biopsy, will be targeted for
      treatment with the NanoKnife System. The primary objective of this the study will be to
      evaluate procedural and short-term post treatment safety of the NanoKnife treatment via
      incidence of adverse events and evaluation of effect on urologic (urinary and erectile)
      function. The secondary objective of this study is to evaluate the short term efficacy of the
      NanoKnife treatment. Local efficacy in the area of treatment will be assessed by histological
      evaluation of transperineal prostate biopsy cores at six (6) months post NanoKnife treatment,
      to evaluate the ablation zone created by the NanoKnife treatment. Other secondary outcomes
      include health-related quality of life levels evaluated using validated patient
      questionnaires. Following the 6 month transperineal prostate biopsy and mpMRI assessment, the
      data from these 6 subjects will be submitted to FDA for confirmation of short term safety and
      efficacy.
    

Trial Arms

NameTypeDescriptionInterventions
NanoKnife ProcedureExperimentalThe NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.

    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)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Treatment procedural and short-term post-treatment safety profile
    Time Frame:6 months
    Safety Issue:
    Description:To determine the NanoKnife treatment procedural and short-term post-treatment safety profile by evaluating adverse event incidence, type, duration, severity and relationship to study device.

    Secondary Outcome Measures

    Measure:Completeness of Ablation
    Time Frame:6 months
    Safety Issue:
    Description:To determine completeness of ablation in the targeted prostate cancer tissue, in relation to probe placement and treatment parameters applied, as determined by histological evaluation of transperineal prostate biopsy cores at six (6) months post- treatment. Determine post-treatment PSA kinetics Determine effectiveness of therapy by post-treatment imaging (necrosis, presence of residual tissue) Determine effectiveness of therapy by rates of biochemical and clinical progression; need for secondary or adjuvant treatment
    Measure:Prostate-Specific Antigen Kinetics
    Time Frame:24 months
    Safety Issue:
    Description:Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.
    Measure:Effectiveness of Therapy
    Time Frame:24 months
    Safety Issue:
    Description:To determine the effectiveness of therapy by post-treatment early-contrast MRI and multiparametric magnetic resonance imaging (mpMRI) to evaluate the area of necrosis and presence of residual tissue.
    Measure:Effectiveness of Therapy
    Time Frame:24 months
    Safety Issue:
    Description:To determine the effectiveness of therapy by recording the rates of biochemical and clinical progression and the need for secondary or adjuvant treatment following therapy.
    Measure:Health-Related Quality of Life
    Time Frame:24 months
    Safety Issue:
    Description:To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Angiodynamics, Inc.

    Trial Keywords

    • Focal
    • Prostate
    • Cancer
    • Irreversible
    • Electroporation
    • NanoKnife

    Last Updated

    July 2, 2021