Recruiting
Phase 3

IRE vs. SBRT

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07548164

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

NanoKnife System

Stereotactic Body Radiation Therapy

Study Details

Brief 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).

Conditions

Prostate Cancer

Study ID

NCT07548164

Start date

Apr 16, 2026

Status verified date

Jun, 2026

Completion date

Apr 16, 2029

Anticipated

Primary completion date

Apr 16, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IRE Boost Arm

Participants will receive Irreversible Electroporation

active comparator: RT Boost Arm

Participants will receive Radiation Therapy and will serve as the control arm

Interventions

NanoKnife 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.

Stereotactic 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.

Primary outcome measure

  • Biopsy negative rate at 2 years [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Himanshu Nagar, MD

212-639-6478nagarh1@mskcc.org

Jonathan Fainberg, MD, MPH

646-422-4894fainberj@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Himanshu Nagar, MD

212-639-6478

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Himanshu Nagar, MD

212-639-6478

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Himanshu Nagar, MD

212-639-6478

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Himanshu Nagar, MD

212-639-6478

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Himanshu Nagar, MD

212-639-6478

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Himanshu Nager, MD

212-639-6478

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Himanshu Nagar, MD

212-639-6478

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • intermediate-risk prostate cancer
  • prostate cancer
  • Memorial Sloan Kettering Cancer Center
  • 26-029

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-16.