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New electric pulse therapy could replace radiation boost for prostate cancer

NCT ID NCT07548164

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This study compares a new boost approach called irreversible electroporation (IRE) using the NanoKnife system against the standard radiation boost for men with intermediate-risk prostate cancer. All participants will receive standard stereotactic body radiation therapy (SBRT), but one group gets an IRE boost while the other gets a radiation boost. The goal is to see if IRE is as effective at clearing cancer cells from the prostate after two years. The trial plans to enroll 224 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NanoKnife System (IRE) and Stereotactic Body Radiation Therapy (SBRT)
What this could lead to
If successful, this could offer a less invasive boost option for prostate cancer that may reduce side effects while maintaining effectiveness.
What could go wrong
This is an early phase 3 trial with 224 participants, so results are not yet known. IRE is a newer technique and may not be as effective as standard radiation, and there are risks from the procedure itself.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Biopsy proven grade group 2 or 3 (GS 3+4 or GS 4+3) cancer with all pattern 4 found only in the MRI target; systematic biopsy pattern 4 that is concordant with MRI target per investigator is permissible * Gland size ≤ 80 cc * Prostate MRI \< rT3b disease * IPSS \< 20 * No contraindication to IRE, RT, anesthesia, or transperineal procedure Exclusion Criteria: * Any Grade Group ≥4 disease, or any cribriform and/or intraductal carcinoma * Evidence of nodal or /metastatic disease on MRI and/or PSMA PET/CT * Unfit for general anesthesia, or contraindication/hypersensitivity to required neuromuscular blocking agents * Active urinary tract infection (UTI) at the time of IRE or biopsy; must be treated and resolved prior to proceeding * Actively bleeding, known bleeding disorder, or inability to interrupt anticoagulants/antiplatelet therapy as clinically indicated for biopsy/IRE safety * Any history of cardiac arrhythmia or epilepsy, or recent myocardial infarction, consistent with NanoKnife contraindication statements * Presence of an implanted pacemaker/defibrillator or other active implanted electronic device, or other device-related contraindications per current NanoKnife labeling/user manual * Inability to undergo pelvic MRI * Prior treatment of prostate cancer including androgen deprivation therapy, focal therapy, radiation therapy, or prostatectomy * Current or intended use of androgen deprivation therapy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activites)

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

    RECRUITING

    Harrison, New York, 10604, United States

  • Weill Cornell Medical Center (Data Collection Only)

    NOT_YET_RECRUITING

    New York, New York, 10021, United States

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