Timothy McClure, MD, highlights data on IRE for prostate tissue ablation

Data from the PRESERVE trial (NCT04972097) were recently published in European Urology, suggesting that irreversible electroporation (IRE) with the NanoKnife System is a safe and effective method for prostate tissue ablation in patients with intermediate-risk prostate cancer.¹

In a recent interview with Urology Times®, Timothy D. McClure, MD, outlined key efficacy and safety data from the study, which supported FDA 510(k) clearance of the NanoKnife System in December 2024.

“It's an encouraging trial showing that focal IRE is really a good treatment option for patients if they're considering focal therapy,” he explained. McClure is an assistant professor of urology at Weill Cornell Medical College in New York, New York.

In total, the prospective, single-arm PRESERVE trial enrolled 121 adult patients with intermediate-risk prostate cancer through 17 clinical trial sites across the US. The primary efficacy end point was the rate of negative in-field biopsy at 12 months, and the primary safety end point was the incidence of adverse events (AEs) through 12 months

Overall, the trial met its primary end point by demonstrating a negative in-field biopsy rate of 71% (95% CI, 62 to 79) at 12 months. When excluding patients without 12-month biopsy data, 80% (95% CI, 72 to 87) had a negative in-field biopsy at 1 year. The negative in-field biopsy rate per Delphi consensus criterion was 84% (95% CI, 76 to 90).

Regarding safety, 86% of patients experienced an AE, with the majority being grade 1 to 2. The most common AEs included hematuria (44%), erectile dysfunction (18%), dysuria (16%), urinary retention (15%), micturition urgency (14%), pollakiuria (12%), and hematospermia (12%).

“Those results are encouraging,” McClure added. “They're comparable to what we see in other single center sites, and I think it shows that there's some limitations, obviously, with the oncologic efficacy of this, but it's a technology that can be delivered nationwide.”

McClure reports relevant disclosures with AngioDynamics.

REFERENCE

1. George AK, Miocinovic R, Patel AR, et al. Irreversible electroporation for prostate tissue ablation in patients with intermediate-risk prostate cancer: Results from the PRESERVE trial. Eur Urol. 2025:S0302-2838(25)00346-X. doi:10.1016/j.eururo.2025.06.003