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

Sponsor

Angiodynamics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04972097

Collaborator

(none)

118

Enrollment

Locations

Arm

23.1

Anticipated Duration (Months)

16.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

118 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 :

Mar 29, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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 Names: The NanoKnife System

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 Names:

The NanoKnife System

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.
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®).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Aurora	Colorado	United States	80045
2	University of Florida Health	Gainesville	Florida	United States	32610
3	Duly Health and Care	Lisle	Illinois	United States	60532
4	Mayo Clinic	Rochester	Minnesota	United States	55905
5	Northwell Health	New York	New York	United States	10022
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	University of Cincinnati	Cincinnati	Ohio	United States	45221