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NCT Number: NCT07548164

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

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).

Recruiting

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SBRT

Primary outcomes

  1. Biopsy negative rate at 2 years

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Himanshu Nagar, MD

CONTACT

[email protected]

212-639-6478

Jonathan Fainberg, MD, MPH

CONTACT

[email protected]

646-422-4894

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Angiodynamics, Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 23, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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