AzTrials
AzTrials

Prostate CancerNCT01972867

Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk Patients

A study testing NanoKnife Procedure in people with Prostate Cancer, run by Angiodynamics, Inc. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
NanoKnife Procedure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
13 May 2021to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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
  • A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6mm linear extent of cancer-bearing tissue in a single core on standard biopsy.
  • Must sign a written informed consent
  • Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Surgery for prostate cancer
  • Have had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
  • Have had prior major rectal surgery (except hemorrhoids)
  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Pilot Study in Human Subjects Evaluating the Use of the NanoKnife System for Ablation of Prostate Cancer Tissue in an Intermediate Risk Patient Population

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.

Read the detailed description

This study will involve six (6) subjects who meet the intermediate risk prostate cancer criteria defined by this protocol. The biopsy and imaging techniques that we will adopt within this trial are multiparametric MRI (mpMRI) and transperineal prostate biopsy (template mapping and/or limited targeted). The subjects' prostate cancer foci, the location of which will be determined by ultrasound guided transperineal prostate biopsy, will be targeted for treatment with the NanoKnife System. The primary objective of this the study will be to evaluate procedural and short-term post treatment safety of the NanoKnife treatment via incidence of adverse events and evaluation of effect on urologic (urinary and erectile) function. The secondary objective of this study is to evaluate the short term efficacy of the NanoKnife treatment. Local efficacy in the area of treatment will be assessed by histological evaluation of transperineal prostate biopsy cores at six (6) months post NanoKnife treatment, to evaluate the ablation zone created by the NanoKnife treatment. Other secondary outcomes include health-related quality of life levels evaluated using validated patient questionnaires. Following the 6 month transperineal prostate biopsy and mpMRI assessment, the data from these 6 subjects will be submitted to FDA for confirmation of short term safety and efficacy.

Conditions
Prostate Cancer
Being tested
NanoKnife Procedure
Keywords
Focal, Prostate, Cancer, Irreversible, Electroporation, NanoKnife
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NanoKnife ProcedureDevice

    Also called NanoKnife

    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.

Study groups in NCT01972867
Study groupRoleWhat they receive
NanoKnife ProcedureExperimentalThe NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.
Receives: Device: NanoKnife Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Treatment Morbidity Profile

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

    Measured: 6 months

Secondary outcomes (5)

  1. Completeness of Ablation

    To determine completeness of ablation in the targeted prostate cancer tissue, in relation to probe placement and treatment parameters applied, as determined by histological evaluation of transperineal prostate biopsy cores at six (6) months post- treatment.

    • Determine post-treatment PSA kinetics
    • Determine effectiveness of therapy by post-treatment imaging (necrosis, presence of residual tissue)
    • Determine effectiveness of therapy by rates of biochemical and clinical progression; need for secondary or adjuvant treatment

    Measured: 6 months

  2. Prostate-Specific Antigen Kinetics

    Determine post-NanoKnife treatment prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability.

    Measured: 24 months

  3. Effectiveness of Therapy

    To determine the effectiveness of therapy by post-treatment early-contrast MRI and multiparametric magnetic resonance imaging (mpMRI) to evaluate the area of necrosis and presence of residual tissue.

    Measured: 24 months

  4. Effectiveness of Therapy

    To determine the effectiveness of therapy by recording the rates of biochemical and clinical progression and the need for secondary or adjuvant treatment following therapy.

    Measured: 24 months

  5. Health-Related Quality of Life

    To determine health-related quality of life (HRQoL) levelsafter NanoKnife using validated patient questionnaires.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2013 (estimated)
  2. Study start13 May 2021
  3. Primary completion1 Nov 2022
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01972867
Sponsor's protocol ID
ON-NK310
Status last verified
Jan 2023
First submitted
23 Oct 2013
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing NanoKnife Procedure in people with Prostate Cancer, run by Angiodynamics, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment procedural and short-term post-treatment safety profile (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01972867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in