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
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Focal, Prostate, Cancer, Irreversible, Electroporation, NanoKnife
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)
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
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
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
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
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
No
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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