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Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue (PRESERVE)

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ClinicalTrials.gov Identifier: NCT04972097
Recruitment Status : Active, not recruiting
First Posted : July 22, 2021
Last Update Posted : August 4, 2023
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Irreversible Electroporation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population
Actual Study Start Date : March 29, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: IRE Treatment Arm
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
 Device: 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 Name: The NanoKnife System


Outcome Measures
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Primary Outcome Measures :
  1. Rate of negative in-field biopsy at 12 months [ Time Frame: 12 months ]
    To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months

  2. Incidence of adverse events by type and CTCAE v5.0 severity through 12 months [ Time Frame: 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


Secondary Outcome Measures :
  1. Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion [ Time Frame: 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)

  2. Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite [ Time Frame: 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.

  3. Assessment of erectile function by comparison of pre- and post-operative IIEF-15 potency scores [ Time Frame: 12 months ]
    Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores.

  4. Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics [ Time Frame: 12 months ]
    Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir.

  5. Assessment of changes in prostate volume [ Time Frame: 12 months ]
    Assessment of changes in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI.

  6. Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI [ Time Frame: 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.

  7. Assessment of need for secondary or adjuvant treatment [ Time Frame: 12 months ]
    Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System.

  8. Evaluation of subject reported pre- and post-operative Quality of Life [ Time Frame: 12 months ]
    Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQol (EQ-5D®).


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04972097


Locations
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Sponsors and Collaborators
Angiodynamics, Inc.
Investigators
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Principal Investigator: Jonathan Coleman, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Arvin George, MD University of Michigan
More Information
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Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT04972097    
Other Study ID Numbers: 2021-ONC-01
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: August 4, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Angiodynamics, Inc.:
Prostate Cancer
Prostate Tissue
NanoKnife System
 Focal Therapy
Intermediate-Risk
Irreversible Electroporation (IRE)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases