Irreversible electroporation (IRE) versus standard radiation boost for intermediate-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with intermediate-risk prostate cancer (grade group 2 or 3, gland ≤80 cc, MRI-confined disease) receive standard stereotactic body radiotherapy (SBRT) and are assigned to either a focal IRE boost using the NanoKnife system or the standard radiation boost. The comparison focuses on cancer control, urinary and sexual function, and treatment-related side effects measured by PSA, imaging, and patient-reported outcomes. Procedures include transperineal IRE under general anesthesia, SBRT delivery, and scheduled follow-up visits with PSA and MRI as indicated. Safety monitoring will track adverse events related to IRE, anesthesia, and radiation during and after treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Himanshu Nagar, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Himanshu Nagar, MD
• Email: nagarh1@mskcc.org
• Phone: 212-639-6478

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.