The PRESERVE trial (NCT04972097), which is assessing the safety and effectiveness of irreversible electroporation (IRE) for prostate tissue ablation, is awaiting a decision from the FDA. Arvin K. George, MD, Associate Professor of Clinical Urology and Director of Prostate Cancer Programs at Johns Hopkins Medicine, provided an update indicating that the results are imminent pending FDA clearance.
Irreversible Electroporation and the PRESERVE Trial
Irreversible electroporation is a technique already FDA-approved for soft tissue ablation. The PRESERVE trial is specifically investigating its application for prostate tissue ablation. A positive outcome and subsequent FDA approval for this specific indication could significantly broaden its use in patients. According to Dr. George, this specific indication "will expand our ability to use it in our patients."
Potential Impact on Prostate Cancer Treatment
If the FDA approves IRE for prostate tissue ablation based on the PRESERVE trial, it would provide a new, targeted treatment option. The results, if positive, may be presented as a late-breaking abstract at the upcoming AUA meeting. The trial's design and specific endpoints have not been fully disclosed, but the focus is on evaluating the safety and effectiveness of IRE in ablating prostate tissue.
