NCT01972867

Brief Summary

The purpose of this study is to evaluate the feasibility and short-term safety and effectiveness of the NanoKnife System when used to ablate localized prostate cancer in intermediate risk subjects with organ-confined prostate cancer. This study will evaluate the feasibility of the NanoKnife System as a focal therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
7.5 years until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

October 23, 2013

Last Update Submit

January 30, 2023

Conditions

Prostate Cancer

Keywords

FocalProstateCancerIrreversibleElectroporationNanoKnife

Outcome Measures

Primary Outcomes (2)

  • Treatment procedural and short-term post-treatment safety profile

    To determine the NanoKnife treatment procedural and short-term post-treatment safety profile by evaluating adverse event incidence, type, duration, severity and relationship to study device.

    6 months

  • Treatment Morbidity Profile

    To determine the NanoKnife treatment morbidity profile by evaluating urinary and erectile function.

    6 months

Secondary Outcomes (5)

  • Completeness of Ablation

    6 months

  • Prostate-Specific Antigen Kinetics

    24 months

  • Effectiveness of Therapy

    24 months

  • Effectiveness of Therapy

    24 months

  • Health-Related Quality of Life

    24 months

Study Arms (1)

NanoKnife Procedure

EXPERIMENTAL

The NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.

Device: NanoKnife Procedure

Interventions

NanoKnife ProcedureDEVICE

Subjects will be placed in the dorsal lithotomy position, under sterile technique. The NanoKnife procedure will be carried out under general anesthesia. A Foley catheter will be placed to aid in draining the bladder during treatment.

Also known as: NanoKnife
NanoKnife Procedure

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has at least a 10-year life expectancy
  • Have histologically confirmed organ-confined prostate cancer - clinical Stage ≤ T2c
  • Have a PSA ≤ 15 ng/mL or PSA density \< 0.15 ng/mL2 if PSA is \> 15 ng/mL
  • Has Gleason score 3+4 or 4+3
  • Has 10 mm or less of cancer-bearing prostate tissue in any biopsy core
  • No evidence of extraprostatic extension or seminal vesicle invasion by mpMRI
  • Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation
  • Transperineal targeted prostate biopsies of lesion, plus 12 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
  • Must sign a written informed consent
  • Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits

You may not qualify if:

  • Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
  • Unfit for anesthesia or have a contraindication for agents listed for paralysis
  • Have an active urinary tract infection (UTI)
  • Have a history of bladder neck contracture
  • Are interested in future fertility
  • Have a history (within 3 years) of inflammatory bowel disease
  • Have a concurrent major debilitating illness
  • Had a malignancy within 5 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
  • Have any active implanted electronic device (e.g., pacemaker)
  • Are unable to catheterize due to a urethral stricture disease
  • Have 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 31, 2013

Study Start

May 13, 2021

Primary Completion

November 1, 2022

Study Completion

May 1, 2024

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

US(2)