Citations 2
A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial
George, Arvin K. , Miocinovic, Ranko, Lomas, Derek J. , Chen, David Y. T., Rastinehad, Ardeshir R. , Schwartz, Michael J. , Uchio, Edward , Sidana, Abhinav , Gahan, Jeffrey , Yu, Alice , Vourganti, Srinivas , Barqawi, Al B. , Brisbane, Wayne , Wysock, James , Polascik, Thomas J. , McClure, Timothy, Rastinehad, Ardeshir R , Schwartz, Michael J , Patel, Amit R. , Correa, Andres F. , Chen, David Y.T. , Helfand, Brian T. , Polascik, Thomas J. , Coleman, Jonathan
Cancers | June 10, 2024 | Volume: 16 | Issue: 12 | Pages: 2178
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.
NCCN Guidelines® Insights: Prostate Cancer Early Detection, Version 1.2023
Moses, Kelvin A. , Sprenkle, Preston C. , Box, Geoffrey N., Carlsson, Sigrid , Catàlona, William J. , Dahl, Douglas M. , Dall’Era, Marc , Davis, John W. , Epstein, Jonathan I. , Etzioni, Ruth B., Farrington, Thomas A., Garraway, Isla P. , Jarrard, David F. , Kauffman, Eric, Kaye, Deborah R. , Kibel, Adam S. , LaGrange, Chad A. , Maroni, Paul, Ponsky, Lee , Salami, Simpa S. , Shaneyfelt, Terrence, Smaldone, Marc C. , Sonn, Geoffrey A. , Tyson, Mark D. , Vapiwala, Neha , Wake, Robert, Washington, Samuel L. , Yu, Alice , Yuh, Bertram, Berardi, Ryan A., Freedman-Cass, Deborah A., Salami, Simpa S , Bahler, Clinton D. , Drake, Bettina F. , Etzioni, Ruth B., Reys, Brian D. , Sánchez, Alejandro , Seibert, Tyler M.
Journal of the National Comprehensive Cancer Network | March 10, 2023 | Volume: 21 | Issue: 3 | Pages: 236-246
The NCCN Guidelines for Prostate Cancer Early Detection provide recommendations for individuals with a prostate who opt to participate in an early detection program after receiving the appropriate counseling on the pros and cons. These NCCN Guidelines Insights provide a summary of recent updates to the NCCN Guidelines with regard to the testing protocol, use of multiparametric MRI, and management of negative biopsy results to optimize the detection of clinically significant prostate cancer and minimize the detection of indolent disease.