Clinical Trials /

Pilot Study of NanoKnife for Ablation of Prostate Cancer in Low and 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 low and intermediate risk subjects with organ-confined prostate cancer and a low risk of recurrence.2 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: Pilot Study of NanoKnife for Ablation of Prostate Cancer in Low Risk Patients
  • Official Title: A Pilot Study in Human Subjects Evaluating the Use of the NanoKnife System for Ablation of Prostate Cancer Tissue in a Low 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 low risk subjects with organ-confined prostate cancer and a low risk of recurrence. This study will evaluate the feasibility of the NanoKnife™ System as a focal therapy.

Detailed Description

      This study is designed to be a prospective, non-randomized pilot study in 6 subjects treated
      at up to three (3) clinical sites. This study will involve six (6) subjects who meet the low
      risk prostate cancer criteria defined by this protocol. The subjects' prostate cancer foci,
      the location of which will be determined by ultrasound guided transperineal 3-Dimensional
      Prostate Mapping Biopsy (3D-PMB), will be targeted for treatment with the NanoKnife System.
      The primary objective of this portion of 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 via histological evaluation of
      3D-PMB cores obtained throughout the half of the prostate where treatment was targeted at
      three (3) months post NanoKnife treatment, to evaluate the ablation zone created by the
      NanoKnife treatment. Following the 3 month biopsy assessment the data from these 6 subjects
      will be submitted to FDA for confirmation of short term safety and efficacy.

      This group of subjects will continue to be followed for safety and efficacy for 2 years.
      Safety will be assessed via incidence of adverse events and evaluation of effect on urologic
      function and quality of life. Local efficacy will be characterized via MR imaging and
      evaluated via post treatment prostate-specific antigen (PSA) kinetics including time to PSA
      nadir and post-nadir PSA stability.
    

Trial Arms

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

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Ages 50-70 years,
    
              2. Have histologically confirmed organ-confined prostate cancer - Clinical Stage T1 or
                 T2a,
    
              3. Have a PSA less than 10 ng/mL,
    
              4. Have a PSA density less than 0.15 ng/ml/cc,
    
              5. Have a PSA velocity less than 2 ng/ml yearly in the year prior to diagnosis,
    
              6. Has no Gleason grade 4 or 5,
    
              7. Has a single lesion with a maximum size of ≤ 12 mm with ≤ 10 mm of capsular contact
                 as confirmed by MR imaging,
    
              8. Has ≤20% of cancer in any biopsy core,
    
              9. Has ≤ 7 mm of cancer in any biopsy core,
    
             10. Has ≤ 33% positive biopsy cores
    
             11. No evidence of extraprostatic extension or seminal vesicle invasion by MRI,
    
             12. Able to visualize prostate gland adequately on transrectal ultrasound imaging during
                 enrollment evaluation,
    
             13. Has no prostate calcification greater than 5 mm in the treatment zone, as noted by
                 TRUS,
    
             14. Has the ability to stop anticoagulant and anti-platelet therapy for seven days prior
                 to and seven days post procedure,
    
             15. Must sign a written informed consent,
    
             16. 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, atracurium or cisatracurium,
    
              2. Have known hypersensitivity to ciprofloxacin or any member of the quinolone class of
                 antimicrobial agents,
    
              3. Have anesthesia surgical assignment category IV or greater,
    
              4. Have a bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds,
                 partial thromboplastin time (PTT) > 34 seconds, and platelet count < 140,000
                 platelets per microliter of circulating blood1
    
              5. Have an active urinary tract infection (UTI),
    
              6. Have a history of bladder neck contracture,
    
              7. Are interested in future fertility,
    
              8. Have a history (within 3 years) of inflammatory bowel disease,
    
              9. Have a concurrent major debilitating illness,
    
             10. Had a malignancy, other than prostate or skin cancer (except malignant melanoma),
                 within 5 years,
    
             11. Have any active implanted electronic device (e.g., pacemaker),
    
             12. Are unable to catheterize due to a urethral stricture disease,
    
             13. 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,
    
             14. Have had prior transurethral prostatectomy (TURP), or urethral stent,
    
             15. Have had prior major rectal surgery (except hemorrhoids).
          
    Maximum Eligible Age:70 Years
    Minimum Eligible Age:50 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Safety
    Time Frame:3 months post procedure
    Safety Issue:
    Description:To determine safety by evaluating AE incidence, type, duration, severity and relationship to study device. Determine morbidity profile by evaluating urinary and erectile function

    Secondary Outcome Measures

    Measure:Procedural Effects
    Time Frame:2 Years
    Safety Issue:
    Description:Secondary Objectives To determine completeness of ablation in the targeted prostate cancer tissue as 3D-PMB at 3 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

    Details

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

    Trial Keywords

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

    Last Updated

    February 10, 2016