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RecruitingInterventionalPhase 3

Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)

NCT ID: NCT07548164Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-06-16

Summary

In this study the investigators will find out whether the use of a new type of boost approach called irreversible electroporation (IRE) is as effective as the standard boost approach of radiation therapy for participants with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).

Arms & interventions

  • DeviceNanoKnife System

    The NanoKnife System is the device that is used for Irreversible Electroporation/IRE. The NanoKnife Generator is a microprocessor-controlled low energy direct current (LEDC) irreversible electroporation device.

  • RadiationStereotactic Body Radiation Therapy

    Radiation-based treatment intensification involves delivery of a boost to the dominant intraprostatic lesion (DIL) to a higher dose than the surrounding prostate tissue using external beam radiation therapy.

Outcome measures

Primary

  • Biopsy negative rate at 2 years

    The primary objective is to demonstrate that Irreversible Electroporation/IRE boost is non-inferior with respect to negative biopsy rate at 2 years compared to Radiation Therapy/RT boost. This is measured by the two-year biopsy negative rate for the control group and the intervention group.

    Time frame: 2 years

Eligibility criteria

Sex: MaleAge: All agesHealthy volunteers: No
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

Study locations (8)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Himanshu Nagar, MD · Contact

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Himanshu Nagar, MD · Contact

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Himanshu Nagar, MD · Contact

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725

Recruiting
Himanshu Nagar, MD · Contact

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Recruiting
Himanshu Nagar, MD · Contact

Weill Cornell Medical Center (Data Collection Only)

New York, New York, 10021

Not Yet Recruiting
Timothy McClure, MD, MS · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065

Recruiting
Himanshu Nager, MD · Contact

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

Recruiting
Himanshu Nagar, MD · Contact