AngioDynamics has reported two-year findings from the PRESERVE pivotal trial, showing durable outcomes for the NanoKnife irreversible electroporation (IRE) system in treating intermediate-risk prostate cancer.
The single-arm, prospective pivotal investigational device exemption (IDE) trial evaluated focal IRE using NanoKnife in 121 patients with Gleason Grade Group two to three intermediate-risk prostate cancer.
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It was conducted in 17 clinical centres in the US, in partnership with the Society of Urologic Oncology Clinical Trials Consortium.
Previously published one-year results showed an 80% freedom-from-treatment-failure rate among protocol-biopsied patients.
At the 24-month mark, the analysis found durable outcomes. A total of 94.4% of analysis-eligible trial participants (68 out of 72) completed the two-year assessment, reflecting strong cohort retention.
No new treatment failures were observed among patients with available 24-month follow-up data. Only one participant (1.5%) had a clinically indicated biopsy, which yielded negative results for cancer.
At 24 months, 97% of patients demonstrated lower prostate-specific antigen (PSA) levels compared to baseline, and no new device- or procedure-related adverse events were observed between the 12- and 24-month time points.
These updated findings add to the existing international long-term evidence for focal IRE.
AngioDynamics scientific and clinical affairs senior vice-president Juan Carlos Serna said: “Two years of prospective pivotal data in the US, combined with more than five years of international follow-up evidence, paints a coherent and compelling picture of sustained efficacy.
“These results reinforce that the NanoKnife System is a clinically meaningful focal therapy option that physicians across care settings are actively incorporating into practice.”
Earlier this year, AngioDynamics expanded indications across Europe for its NanoKnife System to include soft tissue ablation for tumours in the liver, kidney, prostate and pancreas, including use in patients with intermediate-risk prostate cancer.
