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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Memorial Sloan Kettering Cancer Center • ClinicalTrials.gov ID: NCT07548164

Registry updated: 2026-09-18
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Description

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).

Interventions

  • NanoKnife System (Device)
    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.
  • Stereotactic Body Radiation Therapy (Radiation)
    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.

Eligibility criteria

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

Conditions

Prostate Cancer

Locations

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
  • Memorial Sloan Kettering at Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States
  • Memorial Sloan Kettering at Westchester (Limited Protocol Activities) — Harrison, New York, United States
  • Weill Cornell Medical Center (Data Collection Only) — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States
  • Memorial Sloan Kettering at Nassau (Limited Protocol Activities) — Uniondale, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record