Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07548164

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum 99 Years
• Gender: Male

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
• 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

View trial on ClinicalTrials.gov