NanoKnife IRE Yields 71% 12‑mo Negative Biopsy While Preserving Function in Intermediate‑Risk Prostate Cancer

Irreversible electroporation (IRE) with the NanoKnife system—brief, high‑voltage pulses that perforate cell membranes without thermal damage—was evaluated in the single‑arm pivotal PRESERVE trial (NCT04972097). 121 U.S. men with organ‑confined grade‑group 2‑3 (intermediate risk) prostate cancer received focal IRE; at 12 months, 71% (95% CI 62‑79) had a negative in‑field biopsy (84% by Delphi consensus). Median PSA fell 68% by 6 months; urinary scores rose only 3 points, and 84% of men with good erectile baseline function retained it. Grade ≥3 adverse events occurred in 12% (three procedure‑related). For comparison, focal HIFU reports ~82% 12‑mo negative‑biopsy rates, whereas radical prostatectomy causes erectile dysfunction in ~70% of patients at one year, underscoring the functional edge of IRE.