AngioDynamics has today announced the publication of results from the PRESERVE study, which assessed the safety and effectiveness of irreversible electroporation (IRE) with the NanoKnife system to ablate prostate tissue in patients with intermediate-risk prostate cancer in the journal European Urology.
The NanoKnife system is a leading non-thermal, radiation-free, ablation technology designed to treat prostate tissue by using IRE technology, offering patients a minimally invasive option for prostate treatment. In a recent press release, the company has stated that, unlike thermal ablation, IRE avoids damaging critical structures, helping preserve urinary and sexual function.
“The publication of the PRESERVE study in European Urology provides strong supporting evidence for the use of irreversible electroporation as a focal therapy in prostate treatment,” said Juan Carlos Serna, AngioDynamics senior vice president of Scientific and Clinical Affairs. “This is an important milestone for patients and providers seeking new options beyond traditional whole-gland therapies. These results reinforce the NanoKnife system’s role in helping patients receive effective treatment while preserving quality of life, particularly urinary and sexual function, which are often impacted by conventional treatments.”
The NanoKnife system received US Food and Drug Administration (FDA) clearance for prostate tissue ablation in late 2024, following the successful completion of the PRESERVE study. Conducted across 17 clinical sites in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), the trial enrolled 121 patients who met the key inclusion criteria: >50 years of age with organ-confined, grade group two or three intermediate-risk prostate cancer, clinical stage ≤T2c, prostate-specific antigen (PSA) ≤15ng/mL, or PSA density <0.15ng/mL2.
The PRESERVE clinical study met its primary effectiveness endpoint, demonstrating the performance of the NanoKnife system for the ablation of prostate tissue in patients with intermediate-risk prostate cancer. At 12 months post-procedure, 84% of men were free from in-field, clinically significant disease (defined by the Delphi consensus criterion). The study also demonstrated strong quality-of-life outcomes: urinary continence was largely preserved (97% at baseline vs. 96% at 12 months), and at 12 months, 84% of patients with good baseline sexual function-maintained erections sufficient for penetration. These results confirm the NanoKnife system’s robust safety and efficacy profile, building on a foundation of more than 32 clinical studies involving over 2,600 patients worldwide, the company states.
The PRESERVE study was led by co-principal Investigators Jonathan Coleman, a urologic surgeon at Memorial Sloan Kettering Cancer Center, New York, USA and Arvin George, a urologic oncologist at Johns Hopkins Medicine in Baltimore, Maryland. George previously practiced at the Veterans Affairs Ann Arbor Healthcare System and Michigan Medicine.
“The PRESERVE data supports the long-term data that we are seeing in practice, patients are benefiting from effective, targeted treatment without compromising their quality of life,” said Coleman. “The ability to preserve urinary and sexual function while treating prostate tissue with precision is a meaningful advancement for both clinicians and patients.”
