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Two-Year Outcomes from the PRESERVE Trial: Durable Oncologic Control Following Focal Irreversible Electroporation Ablation for Intermediate-Risk Prostate Cancer

Coleman, J. A.; George, A. K.

2026-05-13 urology
10.64898/2026.05.08.26352470 medRxiv
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The PRESERVE trial (NCT04972097) is a prospective, single-arm pivotal IDE study evaluating focal irreversible electroporation (IRE) using the NanoKnife System for intermediate-risk prostate cancer. Men with Gleason Grade Group 2-3 disease underwent focal IRE and were followed for durability of oncologic control and safety. At 24 months, 68 patients completed follow-up with no new treatment failures identified. PSA levels were below baseline in 97% of patients, and one clinically triggered biopsy was negative for cancer. No new device- or procedure-related adverse events occurred beyond 12 months. These findings demonstrate durable efficacy and sustained safety of focal IRE.

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