NanoKnife focal irreversible electroporation (IRE) shows no new failures at 2 years in intermediate-risk prostate cancer

PRESERVE (NCT04972097) is a prospective, single-arm pivotal FDA IDE study testing focal irreversible electroporation (IRE) with the NanoKnife System—an athermal, high-voltage electrical pulse ablation approach intended to kill cells via permanent membrane permeabilization—in men with Gleason Grade Group 2–3 localized prostate cancer. At 24 months, 68 men had completed follow-up with no new treatment failures reported; PSA remained below baseline in 97%, and the only clinically triggered biopsy was negative (n=1). No new device- or procedure-related adverse events were reported beyond 12 months; however, because this is single-arm with limited mandated biopsy data at 24 months, it’s hard to benchmark against definitive standard options (radical prostatectomy or radiotherapy) that typically deliver excellent long-term control but at the cost of urinary/sexual/bowel toxicity tradeoffs, and it’s also hard to compare against active monitoring where many men avoid treatment for years but accept higher rates of progression/metastasis over long follow-up.