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

AngioDynamics

Status

Completed

Conditions

Prostate Cancer

Treatments

Device: Irreversible Electroporation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04972097

2021-ONC-01

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

Male

Ages

50+ years old

Volunteers

No 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:
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
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)