New electric pulse therapy could replace radiation boost for prostate cancer
NCT ID NCT07548164
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 224 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Memorial Sloan Kettering Cancer Center (All Protocol Activites)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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Weill Cornell Medical Center (Data Collection Only)
NOT_YET_RECRUITINGNew York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?