Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
PRESERVE
1 other identifier
interventional
121
1 country
17
Brief Summary
Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Mar 2022
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedStudy Start
First participant enrolled
March 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2024
CompletedFebruary 12, 2025
February 1, 2025
2.4 years
July 2, 2021
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of negative in-field biopsy at 12 months
To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months
12 months
Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
To determine the NanoKnife System's procedural and post-procedural safety profile by evaluation adverse event incidence, type, and severity through 12 months
12 months
Secondary Outcomes (8)
Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion
12 months
Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite
12 months
Assessment of erectile function by comparison of pre- and post-operative IIEF-15 potency scores
12 months
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics
12 months
Assessment of changes in prostate volume
12 months
- +3 more secondary outcomes
Study Arms (1)
IRE Treatment Arm
EXPERIMENTALAll patients enrolled in this trial will receive IRE treatment with the NanoKnife System
Interventions
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.
Eligibility Criteria
You may qualify if:
- Is greater than 50 years of age
- Has at least a 10-year life expectancy
- Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
- Has a PSA ≤ 15 ng/mL or PSA density \< 0.2 ng/mL2 if PSA is \> 15 ng/mL
- Has Gleason score 3+4 or 4+3
- Has no evidence of extraprostatic extension by mpMRI
- Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy
- Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation
- 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
- Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
You may not qualify if:
- Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
- Is unfit for anesthesia or has a contraindication for agents listed for paralysis
- Has an active urinary tract infection (UTI)
- Has a history of bladder neck contracture
- Is interested in future fertility
- Has a history (within 3 years) of inflammatory bowel disease
- Has a concurrent major debilitating illness
- Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
- Has any active implanted electronic device (e.g., pacemaker)
- Is unable to catheterize due to a urethral stricture disease
- Has 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
University of California Irvine
Orange, California, 92868, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Florida Health
Gainesville, Florida, 32610, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Northshore University Healthsystem
Evanston, Illinois, 60201, United States
Duly Health and Care
Lisle, Illinois, 60532, United States
VA Ann Arbor Health Care
Ann Arbor, Michigan, 48105, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
NYU Langone Health
New York, New York, 10017, United States
Northwell Health
New York, New York, 10022, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45221, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Coleman, MD
Memorial Sloan Kettering Cancer Center
- PRINCIPAL INVESTIGATOR
Arvin George, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2021
First Posted
July 22, 2021
Study Start
March 29, 2022
Primary Completion
August 14, 2024
Study Completion
August 14, 2024
Last Updated
February 12, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share