A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial

Arvin K George^{1

2

3}, Ranko Miocinovic⁴, Amit R Patel⁴, Derek J Lomas⁵, Andres F Correa⁶, David Y T Chen⁶, Ardeshir R Rastinehad⁷, Michael J Schwartz⁷, Edward M Uchio⁸, Abhinav Sidana^{9

10}, Brian T Helfand¹¹, Jeffrey C Gahan¹², Alice Yu¹³, Srinivas Vourganti¹⁴, Al Baha Barqawi¹⁵, Wayne G Brisbane¹⁶, James S Wysock¹⁷, Thomas J Polascik¹⁸, Timothy D McClure¹⁹, Jonathan A Coleman²⁰

Affiliations

¹ VA Ann Arbor Health System, Ann Arbor, MI 48105, USA.
² Michigan Medicine, Ann Arbor, MI 48109, USA.
³ Johns Hopkins University, Brady Urological Institute, Baltimore, MD 21287, USA.
⁴ Duly Health and Care, Downers Grove, IL 60515, USA.
⁵ Mayo Clinic, Rochester, MN 55905, USA.
⁶ Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
⁷ Northwell Health System, Manhasset, NY 11030, USA.
⁸ University of California, Irvine, Irvine, CA 92697, USA.
⁹ University of Cincinnati, College of Medicine, Cincinnati, OH 45221, USA.
¹⁰ University of Chicago, Section of Urology, Chicago, IL 60637, USA.
¹¹ Northshore University HealthSystem, Northshore University HealthSystem Research Institute, Evanston, IL 60201, USA.
¹² University of Texas, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
¹³ Moffitt Cancer Center, Tampa, FL 33612, USA.
¹⁴ Rush University, Rush University Medical Center, Chicago, IL 60612, USA.
¹⁵ University of Colorado, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
¹⁶ University of Florida, Gainesville, Gainesville, FL 32611, USA.
¹⁷ NYU Langone Health, NYU Grossman School of Medicine, New York, NY 10016, USA.
¹⁸ Duke University, Duke University School of Medicine, Durham, NC 27705, USA.
¹⁹ Cornell University, Weill Medical College, New York, NY 10065, USA.
²⁰ Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.

PMID: 38927884
PMCID: PMC11201469
DOI: 10.3390/cancers16122178

A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial

Arvin K George et al. Cancers (Basel). 2024.

. 2024 Jun 8;16(12):2178.

doi: 10.3390/cancers16122178.

Authors

Affiliations

¹ VA Ann Arbor Health System, Ann Arbor, MI 48105, USA.
² Michigan Medicine, Ann Arbor, MI 48109, USA.
³ Johns Hopkins University, Brady Urological Institute, Baltimore, MD 21287, USA.
⁴ Duly Health and Care, Downers Grove, IL 60515, USA.
⁵ Mayo Clinic, Rochester, MN 55905, USA.
⁶ Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
⁷ Northwell Health System, Manhasset, NY 11030, USA.
⁸ University of California, Irvine, Irvine, CA 92697, USA.
⁹ University of Cincinnati, College of Medicine, Cincinnati, OH 45221, USA.
¹⁰ University of Chicago, Section of Urology, Chicago, IL 60637, USA.
¹¹ Northshore University HealthSystem, Northshore University HealthSystem Research Institute, Evanston, IL 60201, USA.
¹² University of Texas, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
¹³ Moffitt Cancer Center, Tampa, FL 33612, USA.
¹⁴ Rush University, Rush University Medical Center, Chicago, IL 60612, USA.
¹⁵ University of Colorado, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
¹⁶ University of Florida, Gainesville, Gainesville, FL 32611, USA.
¹⁷ NYU Langone Health, NYU Grossman School of Medicine, New York, NY 10016, USA.
¹⁸ Duke University, Duke University School of Medicine, Durham, NC 27705, USA.
¹⁹ Cornell University, Weill Medical College, New York, NY 10065, USA.
²⁰ Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.

PMID: 38927884
PMCID: PMC11201469
DOI: 10.3390/cancers16122178

Abstract

The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0-72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3-82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.

Keywords: ablation; clinical trial; focal therapy; irreversible electroporation; prostate cancer.

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Conflict of interest statement

This trial was funded by AngioDynamics, Inc. As the sponsor of this study, AngioDynamics wrote the study protocol, performed the data analysis, and made the decision to publish the results. Beyond the institutional research grants received for participation in the trial, these authors declare the following financial conflicts of interest: A.K.G.—CIVCO Medical Solutions, BK Medical, Sonablate Corporation, HIFU Prostate Services; R.M.—AngioDynamics; A.R.P.—AngioDynamics; D.J.L.—CIVCO Medical Solutions; D.Y.T.C.—Pfizer; E.M.U.—Merck, Pfizer, Janssen, CG Oncology; A.S.—AngioDynamics, Janssen, AstraZeneca, Myovant Sciences, SonaCare Medical, HIFU Prostate Services, Astellas; A.Y.—AngioDynamics; S.V.—Biobot Surgical, Intuitive Surgical, UroEssentials; W.G.B.—AngioDynamics, EDAP-TMS, Exact Imaging; T.J.P.—Astellas, Ferring, Janssen, Merck; T.D.M.—Johnson and Johnson, General Electric, Boston Scientific, Francis Medical; and J.A.C.—Memorial Sloan Kettering Cancer Center.

Figures

**Figure 1**
Median (IQR) PSA by Timepoint. Circles–point estimate of PSA; Squares/solid lines–IQR; Dotted lines–trend line across visits.

See this image and copyright information in PMC

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A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial

Affiliations

A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Miscellaneous