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

Recruiting now · Phase 3

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT07548164

Run by

Memorial Sloan Kettering Cancer Center

People needed

224

Starts

2026-04-16

Expected to finish

2029-04-16

Last updated by the study team

2026-06-16

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

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; 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

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

Where it is running

• Memorial Sloan Kettering at Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)
• Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering at Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering at Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (enrolling)
• Weill Cornell Medical Center (Data Collection Only) — New York, New York, United States

Full record on ClinicalTrials.gov

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