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

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

Recruiting
Male
Phase 3

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Overview

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

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
  • 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 details
    Prostate Cancer

NCT07548164

Memorial Sloan Kettering Cancer Center

13 May 2026

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