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NCT Number: NCT04972097

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California Irvine, Orange, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)
  • 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

Exclusion criteria

  • 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
  • Surgery for prostate cancer
  • Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
  • Has had prior major rectal surgery (except hemorrhoids)
  • 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))
  • Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder
  • Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons
  • In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)

Treatment and study plan

Irreversible Electroporation

Device

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 names: The NanoKnife System

Primary outcomes

  1. Number of Participants With a Negative In-field Biopsy at 12 Months

    Time frame: 12 months

    Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months

  2. Number of Participants With Device-related Adverse Events Through 12 Months

    Time frame: 12 months

    Number of participants who experienced any adverse event related to the study device during the study

Secondary outcomes

  1. Number of Participants With a Negative In-field Biopsy at 12 Months as Defined by the Delphi Consensus Criterion

    Time frame: 12 months

    Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months, as defined by the Delphi consensus criterion of absence of clinically significant disease (where ≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is considered 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 (range from 0-100 with higher scores representing better quality of life) and International Prostate Symptom Scores (IPSS) (range from 0 to 35 (asymptomatic to very symptomatic)) and IPSS Quality of Life (IPSS-QoL) scores (range from zero (0) indicating Delighted to six (6) indicating Terrible), change from Baseline to 12 Months

  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, change from Baseline to 12 Months (range 0 - 75, higher scores indicate less dysfunction/higher satisfaction)

  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 PSA nadir

  5. Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics, Percent Change From Baseline

    Time frame: 12 months

    Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, percent change from baseline

  6. Assessment of Changes in Prostate Volume

    Time frame: 12 months

    Assessment of percent change in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI.

  7. 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 12 months post-treatment, using the PI-RADS scoring system, a 1-to-5 scale used on prostate MRI to indicate the likelihood of clinically significant prostate cancer, with higher scores suggesting greater suspicion of cancer.

  8. 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.

  9. Evaluation of Subject Reported Pre- and Post-operative Quality of Life, Change From Baseline to 12 Months

    Time frame: 12 months

    Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQoL (EQ-5D®) EQ VAS. Scale ranges from minimum of 0 (worse) to 100 (better/best).

Sponsors and collaborators

Lead sponsor

Angiodynamics, Inc.

Industry

Registry information

Official study title

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population

Acronym: PRESERVE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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