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New NanoKnife treatment shows promise for prostate cancer

NCT ID NCT04972097

Disease control Sponsor: Angiodynamics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called NanoKnife to treat prostate cancer in 121 men with intermediate-risk disease. The goal was to safely destroy cancer tissue while avoiding major side effects. Researchers checked if the treated area was cancer-free after 12 months and tracked any device-related problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

121 people

The number who actually took part.

Started

Mar 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Is greater than 50 years of age 2. Has at least a 10-year life expectancy 3. Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c 4. Has a PSA ≤ 15 ng/mL or PSA density \< 0.2 ng/mL2 if PSA is \> 15 ng/mL 5. Has Gleason score 3+4 or 4+3 6. Has no evidence of extraprostatic extension by mpMRI 7. Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy 8. Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation 9. 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 10. 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) 11. Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject 12. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits Exclusion Criteria: 1. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium 2. Is unfit for anesthesia or has a contraindication for agents listed for paralysis 3. Has an active urinary tract infection (UTI) 4. Has a history of bladder neck contracture 5. Is interested in future fertility 6. Has a history (within 3 years) of inflammatory bowel disease 7. Has a concurrent major debilitating illness 8. Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer 9. Has any active implanted electronic device (e.g., pacemaker) 10. Is unable to catheterize due to a urethral stricture disease 11. 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 12. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants 13. Has had prior major rectal surgery (except hemorrhoids) 14. 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)) 15. Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder 16. Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons 17. In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27710, United States

  • Duly Health and Care

    Lisle, Illinois, 60532, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • NYU Langone Health

    New York, New York, 10017, United States

  • Northshore University Healthsystem

    Evanston, Illinois, 60201, United States

  • Northwell Health

    New York, New York, 10022, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45221, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Florida Health

    Gainesville, Florida, 32610, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • VA Ann Arbor Health Care

    Ann Arbor, Michigan, 48105, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.