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Comparing Boost Approaches in Radiation Therapy for Prostate Cancer

This study is comparing two different ways to boost radiation therapy for men with intermediate-risk prostate cancer. Researchers want to see if using the NanoKnife System (which uses irreversible electroporation, or IRE) is as effective as the standard method of Stereotactic Body Radiation Therapy (SBRT) to target the main tumor within the prostate. You might be able to join if you are a man with certain types of prostate cancer (grade group 2 or 3) and meet other health requirements. The main goal is to see how many participants have no cancer detected by biopsy after two years. The current recruitment status is unclear.

Study design
This study plans to enroll 224 men. It is an interventional study, meaning participants will receive specific treatments as part of the research.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least two years to check for cancer recurrence after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07548164

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

Recruiting
PHASE3All AgesInterventionalTreatment
Memorial Sloan Kettering Cancer Center
~224 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:NanoKnife SystemStereotactic Body Radiation Therapy

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biopsy negative rate at 2 years
Measured over 2 years

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

8 sites across 2 states
New York5
New Jersey3

Study leadership

  • Himanshu Nagar, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Himanshu Nagar, MD
[email protected]
212-639-6478
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Biopsy negative rate at 2 years2 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.