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NCT07548164PHASE3Recruiting

Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer

Memorial Sloan Kettering Cancer Center

Start Date

4/16/2026

Completion Date

4/16/2029

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).

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DEVICE

NanoKnife System

RADIATION

Stereotactic Body Radiation Therapy

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Conditions

Prostate Cancer

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York 11725

United States

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Harrison, New York 10604

United States

Weill Cornell Medical Center (Data Collection Only)

New York, New York 10021

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York 10065

United States

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Uniondale, New York 11553

United States