Irreversible electroporation for prostate tissue ablation in patients with intermediate-risk prostate cancer: Results from the PRESERVE trial Journal Article
| Authors: | George, A. K.; Miocinovic, R.; Patel, A. R.; Lomas, D. J.; Correa, A. F.; Chen, D. Y. T.; Rastinehad, A. R.; Schwartz, M. J.; Sidana, A.; Stensland, K. D.; Helfand, B. T.; Gahan, J. C.; Meng, X.; Yu, A.; Brisbane, W. G.; Vourganti, S.; Barqawi, A. B.; Uchio, E. M.; Wysock, J. S.; Polascik, T. J.; McClure, T. D.; Fainberg, J.; Coleman, J. A. |
| Article Title: | Irreversible electroporation for prostate tissue ablation in patients with intermediate-risk prostate cancer: Results from the PRESERVE trial |
| Abstract: | Background and objective: The PRESERVE study (NCT04972097) assessed the safety and effectiveness of irreversible electroporation (IRE) with the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). Methods: This prospective, nonrandomized, single-arm pivotal trial included patients in the USA who met the key inclusion criteria: age >50 yr with organ-confined, grade group 2 or 3 PCa, clinical stage ≤T2c, prostate-specific antigen (PSA) ≤15 ng/ml, or PSA density <0.15 ng/ml2. The primary endpoints were the rate of local pathological complete response (negative in-field biopsy) and the incidence, type, and severity of adverse events by 12 mo. The secondary endpoints included PSA kinetics, changes in prostate volume, retreatment, and urinary/sexual function. Key findings and limitations: Of the 121 patients treated with IRE, the negative in-field biopsy rate at 12 mo was 71% (95% confidence interval [CI]: 62%, 79%). The secondary endpoint of negative in-field biopsy rate defined by the Delphi consensus criterion was 84% (95% CI: 76%, 90%). The time to median PSA nadir was 3.5 mo, and the median percent reduction in PSA at 6 mo was 68.2%. Urinary function outcomes had a mean change from baseline to 12 mo of 3 in the University of California Los Angeles Expanded Prostate Cancer Index Composite urinary domain total score and a mean change of –2 in the International Prostate Symptom Score total symptom score. At 12 mo, 84% of patients with good baseline sexual function maintained erections sufficient for penetration. Fourteen (12%) patients experienced Common Terminology Criteria for Adverse Events grade ≥3 and three experienced procedure-related grade 3 adverse events. Conclusions and clinical implications: IRE with the NanoKnife System is safe and effective for prostate tissue ablation. © 2025 |
| Keywords: | clinical trial; prostate cancer; ablation; focal therapy; irreversible electroporation |
| Journal Title: | European Urology |
| ISSN: | 0302-2838 |
| Publisher: | Elsevier Science, Inc. |
| Publication status: | Online ahead of print |
| Date Published: | 2025-07-19 |
| Online Publication Date: | 2025-07-19 |
| Language: | English |
| DOI: | 10.1016/j.eururo.2025.06.003 |
| PROVIDER: | scopus |
| PUBMED: | 40685282 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledge in the PDF -- Source: Scopus |
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