NCT07548164

Brief Summary

In this study we 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 people with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
36mo left

Started Apr 2026

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Apr 2029

Study Start

First participant enrolled

April 16, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2029

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 17, 2026

Last Update Submit

April 17, 2026

Conditions

Prostate Cancer

Keywords

intermediate-risk prostate cancerprostate cancerMemorial Sloan Kettering Cancer Center26-029

Outcome Measures

Primary Outcomes (1)

  • Biopsy negative rate at 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.

    2 years

Study Arms (2)

IRE Boost Arm

EXPERIMENTAL

Participants will receive Irreversible Electroporation

Device: NanoKnife SystemRadiation: Stereotactic Body Radiation Therapy

RT Boost Arm

ACTIVE COMPARATOR

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

Radiation: Stereotactic Body Radiation Therapy

Interventions

NanoKnife SystemDEVICE

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.

IRE Boost Arm
Stereotactic Body Radiation TherapyRADIATION

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.

Also known as: SBRT
IRE Boost ArmRT Boost Arm

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Weill Cornell Medical Center (Data Collection Only)

New York, New York, 10021, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Himanshu Nagar, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Himanshu Nagar, MD

CONTACT

212-639-6478nagarh1@mskcc.org

Jonathan Fainberg, MD, MPH

CONTACT

646-422-4894fainberj@mskcc.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

April 16, 2029

Study Completion (Estimated)

April 16, 2029

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(8)