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

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NanoKnife Procedure

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Focal, Prostate, Cancer, Irreversible, Electroporation, NanoKnife

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Has at least a 10-year life expectancy
Have histologically confirmed organ-confined prostate cancer - clinical Stage ≤ T2c
Have a PSA ≤ 15 ng/mL or PSA density < 0.15 ng/mL2 if PSA is > 15 ng/mL
Has Gleason score 3+4 or 4+3
Has 10 mm or less of cancer-bearing prostate tissue in any biopsy core
No evidence of extraprostatic extension or seminal vesicle invasion by mpMRI
Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation
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.
A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment
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.
Must sign a written informed consent
Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria:

Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
Unfit for anesthesia or have a contraindication for agents listed for paralysis
Have an active urinary tract infection (UTI)
Have a history of bladder neck contracture
Are interested in future fertility
Have a history (within 3 years) of inflammatory bowel disease
Have a concurrent major debilitating illness
Had a malignancy within 5 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
Have any active implanted electronic device (e.g., pacemaker)
Are unable to catheterize due to a urethral stricture disease
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
Have had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
Have had prior major rectal surgery (except hemorrhoids)
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)

Sites / Locations

Rush University Medical Center
Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NanoKnife Procedure

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Treatment Morbidity Profile

To determine the NanoKnife treatment morbidity profile by evaluating urinary and erectile function.

Secondary Outcome Measures

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

Prostate-Specific Antigen Kinetics

Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.

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.

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.

Health-Related Quality of Life

To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires.

Full Information

NCT ID

NCT01972867

First Posted

October 23, 2013

Last Updated

January 30, 2023

Sponsor

Angiodynamics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01972867

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 13, 2021 (Actual)

Primary Completion Date

November 1, 2022 (Actual)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Angiodynamics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Focal, Prostate, Cancer, Irreversible, Electroporation, NanoKnife

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NanoKnife Procedure

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

NanoKnife Procedure

Other Intervention Name(s)

NanoKnife

Intervention Description

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.

Primary Outcome Measure Information:

Title

Treatment procedural and short-term post-treatment safety profile

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.

Time Frame

6 months

Title

Treatment Morbidity Profile

Description

To determine the NanoKnife treatment morbidity profile by evaluating urinary and erectile function.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Completeness of Ablation

Description

Time Frame

6 months

Title

Prostate-Specific Antigen Kinetics

Description

Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.

Time Frame

24 months

Title

Effectiveness of Therapy

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.

Time Frame

24 months

Title

Effectiveness of Therapy

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.

Time Frame

24 months

Title

Health-Related Quality of Life

Description

To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires.

Time Frame

24 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has at least a 10-year life expectancy Have histologically confirmed organ-confined prostate cancer - clinical Stage ≤ T2c Have a PSA ≤ 15 ng/mL or PSA density < 0.15 ng/mL2 if PSA is > 15 ng/mL Has Gleason score 3+4 or 4+3 Has 10 mm or less of cancer-bearing prostate tissue in any biopsy core No evidence of extraprostatic extension or seminal vesicle invasion by mpMRI Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation 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. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment 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. Must sign a written informed consent Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits Exclusion Criteria: Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium Unfit for anesthesia or have a contraindication for agents listed for paralysis Have an active urinary tract infection (UTI) Have a history of bladder neck contracture Are interested in future fertility Have a history (within 3 years) of inflammatory bowel disease Have a concurrent major debilitating illness Had a malignancy within 5 years, including malignant melanoma, except for prostate cancer or other types of skin cancer Have any active implanted electronic device (e.g., pacemaker) Are unable to catheterize due to a urethral stricture disease Have 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 Have had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants Have had prior major rectal surgery (except hemorrhoids) 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)

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

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

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