Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Irreversible Electroporation

• Registration Number: NCT04972097
• Lead Sponsor: Angiodynamics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-22
• Study Start: 2022-03-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 121

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRE Treatment Arm	Irreversible Electroporation	All patients enrolled in this trial will receive IRE treatment with the NanoKnife System

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events by type and CTCAE v5.0 severity through 12 months	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
Rate of negative in-field biopsy at 12 months	12 months	To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months

Secondary Outcome Measures

Name	Time	Method
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics	12 months	Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir.
Assessment of changes in prostate volume	12 months	Assessment of changes in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI.
Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI	12 months	Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI at 3 to 10 days post-treatment and at 12 months post-treatment.
Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion	12 months	Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant)
Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite	12 months	Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain and International Prostate Symptom Scores (IPSS) and IPSS Quality of Life2 (IPSS-QoL) scores.
Assessment of erectile function by comparison of pre- and post-operative IIEF-15 potency scores	12 months	Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores.
Assessment of need for secondary or adjuvant treatment	12 months	Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System.
Evaluation of subject reported pre- and post-operative Quality of Life	12 months	Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQol (EQ-5D®).

Trial Locations

Locations (17)

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

University of California Irvine; 🇺🇸 Orange, California, United States

University of Florida Health; 🇺🇸 Gainesville, Florida, United States

Duly Health and Care; 🇺🇸 Lisle, Illinois, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Northshore University Healthsystem; 🇺🇸 Evanston, Illinois, United States

VA Ann Arbor Health Care; 🇺🇸 Ann Arbor, Michigan, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

NYU Langone Health; 🇺🇸 New York, New York, United States