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.
Cancers. 2024 Jun 08*** epublish ***
Arvin K George, Ranko Miocinovic, Amit R Patel, Derek J Lomas, Andres F Correa, David Y T Chen, Ardeshir R Rastinehad, Michael J Schwartz, Edward M Uchio, Abhinav Sidana, Brian T Helfand, Jeffrey C Gahan, Alice Yu, Srinivas Vourganti, Al Baha Barqawi, Wayne G Brisbane, James S Wysock, Thomas J Polascik, Timothy D McClure, Jonathan A Coleman
VA Ann Arbor Health System, Ann Arbor, MI 48105, USA., Duly Health and Care, Downers Grove, IL 60515, USA., Mayo Clinic, Rochester, MN 55905, USA., Fox Chase Cancer Center, Philadelphia, PA 19111, USA., Northwell Health System, Manhasset, NY 11030, USA., University of California, Irvine, Irvine, CA 92697, USA., University of Cincinnati, College of Medicine, Cincinnati, OH 45221, USA., Northshore University HealthSystem, Northshore University HealthSystem Research Institute, Evanston, IL 60201, USA., University of Texas, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA., Moffitt Cancer Center, Tampa, FL 33612, USA., Rush University, Rush University Medical Center, Chicago, IL 60612, USA., University of Colorado, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA., University of Florida, Gainesville, Gainesville, FL 32611, USA., NYU Langone Health, NYU Grossman School of Medicine, New York, NY 10016, USA., Duke University, Duke University School of Medicine, Durham, NC 27705, USA., Cornell University, Weill Medical College, New York, NY 10065, USA., Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.