SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer.
PURPOSE: The SPARED CRN (Study of Prostate Ablation Related Energy Devices Coordinated Registry Network) is a private-public partnership between academic and community urologists, the FDA (U.S. Food and Drug Administration), the Medical Device Epidemiology Network and device manufacturers to examine the safety and effectiveness of technologies for partial gland ablation in men with localized prostate cancer. MATERIALS AND METHODS: We report on a recent workshop at the FDA with thought leaders to discuss a critical framework for partial gland ablation, focusing on patient selection, surgical planning, followup, 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. RESULTS: Given the challenges in achieving patient and physician equipoise to perform a randomized trial, as well as an inherent paradigm shift when comparing partial gland ablation (inability to assess prostate specific antigen recurrence) to whole gland treatments, the group focused on objective performance criteria and goals as a platform to guide the creation of single arm studies in the SPARED CRN. CONCLUSIONS: This summit lays the foundation for prospective, multi-center data collection and evaluation of novel medical devices and drug/device combinations for partial gland ablation.
Gross, MD; Sedrakyan, A; Bianco, FJ; Carroll, PR; Daskivich, TJ; Eggener, SE; Ehdaie, B; Fisher, B; Gorin, MA; Hunt, B; Jiang, H; Klein, EA; Marinac-Dabic, D; Montgomery, JS; Polascik, TJ; Priester, AM; Rastinehad, AR; Viviano, CJ; Wysock, JS; Hu, JC
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