Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
NCT ID: NCT04972097
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
121 participants
INTERVENTIONAL
2022-03-29
2024-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IRE Treatment Arm
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Irreversible Electroporation
IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
Interventions
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Irreversible Electroporation
IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has at least a 10-year life expectancy
3. Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
4. Has a PSA ≤ 15 ng/mL or PSA density \< 0.2 ng/mL2 if PSA is \> 15 ng/mL
5. Has Gleason score 3+4 or 4+3
6. Has no evidence of extraprostatic extension by mpMRI
7. Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy
8. Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation
9. Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 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
10. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment (Note: A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion criterion provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core on standard biopsy)
11. Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject
12. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
Exclusion Criteria
2. Is unfit for anesthesia or has a contraindication for agents listed for paralysis
3. Has an active urinary tract infection (UTI)
4. Has a history of bladder neck contracture
5. Is interested in future fertility
6. Has a history (within 3 years) of inflammatory bowel disease
7. Has a concurrent major debilitating illness
8. Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
9. Has any active implanted electronic device (e.g., pacemaker)
10. Is unable to catheterize due to a urethral stricture disease
11. Has 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. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
13. Has had prior major rectal surgery (except hemorrhoids)
14. Is 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))
15. Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder
16. Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons
17. In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)
50 Years
MALE
No
Sponsors
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Angiodynamics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Coleman, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Arvin George, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of California Irvine
Orange, California, United States
University of Colorado
Aurora, Colorado, United States
University of Florida Health
Gainesville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Northshore University Healthsystem
Evanston, Illinois, United States
Duly Health and Care
Lisle, Illinois, United States
VA Ann Arbor Health Care
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Northwell Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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2021-ONC-01
Identifier Type: -
Identifier Source: org_study_id
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