Clinical trial NCT04972097: Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
Official title: Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostate Tissue
NanoKnife System
Focal Therapy
Intermediate-Risk
Irreversible Electroporation (IRE)
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 121
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Is greater than 50 years of age
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:

1. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
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)

Primary outcomes:
measure: Rate of negative in-field biopsy at 12 months
timeFrame: 12 months
measure: Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion
timeFrame: 12 months
measure: Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite
timeFrame: 12 months
measure: Assessment of erectile function by comparison of pre- and post-operative IIEF-15 potency scores
timeFrame: 12 months
measure: Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics
timeFrame: 12 months
measure: Assessment of changes in prostate volume
timeFrame: 12 months
measure: Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI
timeFrame: 12 months
measure: Assessment of need for secondary or adjuvant treatment
timeFrame: 12 months
measure: Evaluation of subject reported pre- and post-operative Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University Healthsystem
state: Illinois
city: Lisle
country: United States
facility: Duly Health and Care
state: Illinois
city: Ann Arbor
country: United States
facility: VA Ann Arbor Health Care
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jonathan Coleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Arvin George, MD
role: PRINCIPAL_INVESTIGATOR
References: