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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: NanoKnife Procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: NanoKnife

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment procedural and short-term post-treatment safety profile	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.	6 months
Treatment Morbidity Profile	To determine the NanoKnife treatment morbidity profile by evaluating urinary and erectile function.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completeness of Ablation	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	6 months
Prostate-Specific Antigen Kinetics	Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.	24 months
Effectiveness of Therapy	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.	24 months
Effectiveness of Therapy	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.	24 months
Health-Related Quality of Life	To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires.	24 months

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Prostate; Focal; NanoKnife; Electroporation; Irreversible
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: ON-NK310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes