Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial

Arvin K George¹, Ranko Miocinovic², Amit R Patel², Derek J Lomas³, Andres F Correa⁴, David Y T Chen⁴, Ardeshir R Rastinehad⁵, Michael J Schwartz⁵, Abhinav Sidana⁶, Kristian D Stensland⁷, Brian T Helfand⁸, Jeffrey C Gahan⁹, Xiaosong Meng⁹, Alice Yu¹⁰, Wayne G Brisbane¹¹, Srinivas Vourganti¹², Al Baha Barqawi¹³, Edward M Uchio¹⁴, James S Wysock¹⁵, Thomas J Polascik¹⁶, Timothy D McClure¹⁷, Jonathan Fainberg¹⁸, Jonathan A Coleman¹⁸

Affiliations

¹ VA Ann Arbor Health System, Ann Arbor, MI, USA; Michigan Medicine, Ann Arbor, MI, USA; Brady Urological Institute, Johns Hopkins University, Baltimore, MD, USA. Electronic address: ageorg29@jh.edu.
² Duly Health and Care, Downers Grove, IL, USA.
³ Mayo Clinic, Rochester, MN, USA.
⁴ Fox Chase Cancer Center, Philadelphia, PA, USA.
⁵ Northwell Health System, Manhasset, NY, USA.
⁶ College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Section of Urology, University of Chicago, Chicago, IL, USA.
⁷ VA Ann Arbor Health System, Ann Arbor, MI, USA.
⁸ Northshore University HealthSystem, Northshore University HealthSystem Research Institute, Evanston, IL, USA.
⁹ University of Texas Southwestern Medical Center, University of Texas, Dallas, TX, USA.
¹⁰ Moffitt Cancer Center, Tampa, FL, USA.
¹¹ University of Florida, Gainesville, FL, USA.
¹² Rush University Medical Center, Rush University, Chicago, IL, USA.
¹³ University of Colorado Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.
¹⁴ University of California Irvine, Irvine, CA, USA.
¹⁵ NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA.
¹⁶ Duke University, Duke University School of Medicine, Durham, NC, USA.
¹⁷ Cornell University, Weill Medical College, New York, NY, USA.
¹⁸ Memorial Sloan Kettering Cancer Center, New York, NY, USA.

PMID: 40685282
DOI: 10.1016/j.eururo.2025.06.003

Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial

Arvin K George et al. Eur Urol. 2025.

. 2025 Jul 19:S0302-2838(25)00346-X.

doi: 10.1016/j.eururo.2025.06.003. Online ahead of print.

Authors

Affiliations

¹ VA Ann Arbor Health System, Ann Arbor, MI, USA; Michigan Medicine, Ann Arbor, MI, USA; Brady Urological Institute, Johns Hopkins University, Baltimore, MD, USA. Electronic address: ageorg29@jh.edu.
² Duly Health and Care, Downers Grove, IL, USA.
³ Mayo Clinic, Rochester, MN, USA.
⁴ Fox Chase Cancer Center, Philadelphia, PA, USA.
⁵ Northwell Health System, Manhasset, NY, USA.
⁶ College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Section of Urology, University of Chicago, Chicago, IL, USA.
⁷ VA Ann Arbor Health System, Ann Arbor, MI, USA.
⁸ Northshore University HealthSystem, Northshore University HealthSystem Research Institute, Evanston, IL, USA.
⁹ University of Texas Southwestern Medical Center, University of Texas, Dallas, TX, USA.
¹⁰ Moffitt Cancer Center, Tampa, FL, USA.
¹¹ University of Florida, Gainesville, FL, USA.
¹² Rush University Medical Center, Rush University, Chicago, IL, USA.
¹³ University of Colorado Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.
¹⁴ University of California Irvine, Irvine, CA, USA.
¹⁵ NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA.
¹⁶ Duke University, Duke University School of Medicine, Durham, NC, USA.
¹⁷ Cornell University, Weill Medical College, New York, NY, USA.
¹⁸ Memorial Sloan Kettering Cancer Center, New York, NY, USA.

PMID: 40685282
DOI: 10.1016/j.eururo.2025.06.003

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.

Keywords: Ablation; Clinical trial; Focal therapy; Irreversible electroporation; Prostate cancer.

PubMed Disclaimer

LinkOut - more resources

Full Text Sources
- ClinicalKey
- Elsevier Science
Research Materials
- NCI CPTC Antibody Characterization Program
Miscellaneous
- NCI CPTAC Assay Portal

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial

Affiliations

Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial

Authors

Affiliations

Abstract

LinkOut - more resources

Full Text Sources

Research Materials

Miscellaneous