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Pilot Study of NanoKnife for Ablation of Prostate Cancer in Low and Intermediate Risk Patients

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ClinicalTrials.gov Identifier: NCT01972867
Recruitment Status : Not yet recruiting
First Posted : October 31, 2013
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: NanoKnife Procedure Not Applicable

Detailed Description:
This study will involve six (6) subjects who meet the low and 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study in Human Subjects Evaluating the Use of the NanoKnife System for Ablation of Prostate Cancer Tissue in a Low and Intermediate Risk Patient Population
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: NanoKnife Procedure
The NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.
Device: NanoKnife Procedure
Subjects will be placed in the dorsal lithotomy position, under sterile technique. The NanoKnife procedure will be carried out under general anesthesia. A Foley catheter will be placed to aid in draining the bladder during treatment.
Other Name: NanoKnife




Primary Outcome Measures :
  1. Safety [ Time Frame: 6 months ]
    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.

  2. Treatment Morbidity Profile [ Time Frame: 6 months ]
    Determine the NanoKnife treatment morbidity profile by evaluating urinary and erectile function.


Secondary Outcome Measures :
  1. Completeness of Ablation [ Time Frame: 6 months ]

    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

  2. Prostate-Specific Antigen Kinetics [ Time Frame: 24 months ]
    Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.

  3. Effectiveness of Therapy [ Time Frame: 24 months ]
    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.

  4. Effectiveness of Therapy [ Time Frame: 24 months ]
    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.

  5. Health-Related Quality of Life [ Time Frame: 24 months ]
    To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has atleast a 10 year life expectancy
  2. Have histologically confirmed organ-confined prostate cancer - clinical Stage T1 or T2a
  3. Have a PSA less than 10 ng/mL
  4. Has Gleason score 3+3 or 3+4/4+3
  5. Has 10 mm or less of cancer 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 Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with low to intermediate risk lesion1 in the area of the MR-visible lesion (within 2 Barzell zones)

9. An visible lesion on mpMRI, that is accessible to IRE treatment 10. Must sign a written informed consent 11. 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 anthesthia 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, other than prostate or skin cancer (except malignant melanoma), within 5 years
  9. Have any active implanted electronic device (eg, 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), or urethral stent
  13. Have had prior major rectal surgery (except hemorrhoids)
  14. Unfit for pelvic MRI scanning (e.g. severe claustrophobia, permanent cardiac pacemaker, metallic implant etc… likely to contribute significant artefact to images)
  15. Have a prior diagnosis of prostate cancer
  16. Have a non-visible tumor on mpMRI

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Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT01972867    
Other Study ID Numbers: ON-NK310
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Angiodynamics, Inc.:
Focal
Prostate
Cancer
Irreversible
Electroporation
NanoKnife
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases