Study of Prostate Ablation Related Energy Devices (SPARED) Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer.

The Studies of Prostate Ablation Related Energy Devices (SPARED) coordinated registry network (CRN) is a private-public partnership between academic and community urologists, the US Food and Drug Administration (FDA), Medical Device Epidemiology Network (MDEpiNet) and device manufacturers to examine safety and effectiveness of technologies for partial gland ablation (PGA) in men with localized prostate cancer.

We report on a recent workshop at the FDA with thought leaders to discuss a critical framework for PGA, focusing on patient selection, surgical planning, follow up, study design and appropriate comparators in terms of adverse events and cancer control outcomes. We summarize salient points from experts in urology, oncology, and epidemiology that were presented and discussed in an open forum.

Given the challenges in achieving patient and physician equipoise to conduct a randomized trial, as well as an inherent paradigm shift when comparing PGA (inability to assess PSA recurrence) to whole gland treatments, the group focused on objective performance criteria/goals (OPC/OPG) as a platform to guide the creation of single arm studies within the SPARED CRN.

This summit lays the foundation for prospective, multi-center data collection and evaluation of novel medical devices and drug/device combinations for PGA.

The Journal of urology. 2019 May 30 [Epub ahead of print]

Michael D Gross, Art Sedrakyan, Fernando J Bianco, Peter R Carroll, Timothy J Daskivich, Scott E Eggener, Behfar Ehdaie, Benjamin Fisher, Michael A Gorin, Bradley Hunt, Hongying Jiang, Eric A Klein, Danica Marinac-Dabic, Jeffrey S Montgomery, Thomas J Polascik, Alan M Priester, Ardeshir R Rastinehad, Charles J Viviano, James S Wysock, Jim C Hu

Department of Urology, New York Presbyterian-Weill Cornell Medical College , New York , NY., Department of Healthcare Policy and Research, Weill Cornell Medical College , New York , NY., Urological Research Network , Miami Lakes , FL., Department of Urology, University of California , San Francisco CA., Division of Urology, Cedars Sinai Medical Center , Los Angeles , CA., Section of Urology, Department of Surgery, University of Chicago Medical Center , Chicago , IL., Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center , New York , NY., Center for Devices and Radiological Health, United States Food and Drug Administration , Silver Spring , MD., Department of Urology, Johns Hopkins University School of Medicine , Baltimore , MD., Department of Urology, Glickman Urology and Kidney Institute, Cleveland Clinic , Cleveland , OH., Department of Urology, University of Michigan , MI., Duke Cancer Institute, Duke Medical Center , Durham NC., Department of Bioengineering, University of California-Los Angeles , Los Angeles , CA., Department of Interventional Radiology, Mount Sinai Health System , New York , NY., Department of Urology, New York University Langone Medical Center , New York , NY.