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
intermediate risk subjects with organ-confined prostate cancer. This study will evaluate the
feasibility of the NanoKnife System as a focal therapy.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
ON-NK310
- NCT ID:
NCT01972867
Conditions
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
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.
Trial Arms
Name | Type | Description | Interventions |
---|
NanoKnife Procedure | Experimental | The NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance. | |
Eligibility Criteria
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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Treatment procedural and short-term post-treatment safety profile |
Time Frame: | 6 months |
Safety Issue: | |
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. |
Secondary Outcome Measures
Measure: | Completeness of Ablation |
Time Frame: | 6 months |
Safety Issue: | |
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 |
Measure: | Prostate-Specific Antigen Kinetics |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability. |
Measure: | Effectiveness of Therapy |
Time Frame: | 24 months |
Safety Issue: | |
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. |
Measure: | Effectiveness of Therapy |
Time Frame: | 24 months |
Safety Issue: | |
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. |
Measure: | Health-Related Quality of Life |
Time Frame: | 24 months |
Safety Issue: | |
Description: | To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Angiodynamics, Inc. |
Trial Keywords
- Focal
- Prostate
- Cancer
- Irreversible
- Electroporation
- NanoKnife
Last Updated
July 2, 2021