Abstract

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.

irreversible electroporationfocal therapyprostate cancerintermediate-riskNanoKnifeablationPRESERVE trialoncologic outcomesCompeting Interest Statement

Jonathan A. Coleman received funding from American Urological Association, AngioDynamics, Impact Biotech, and Memorial Sloan Kettering Cancer Center. Arvin K. George received funding from AngioDynamics, Francis Medical, Levee Medical, Lantheus, Veracyte, HIFU Prostate Services, Sonablate Corporation, BK Medical, CIVCO, Lina Medical, Levee Medical, Koelis, Boston Scientific, and Histosonics.

Clinical Trial

NCT04972097

Funding Statement

This research was funded by AngioDynamics, Inc.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Patients provided informed consent. The study protocol was approved by institutional review boards and conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript.