Developing a Patient-Reported Outcome Measure for Radionuclide Therapy for Prostate Cancer.

Gudenkauf, Lisa M; Chavez, Melody N; Maconi, Melinda Leigh; Geiss, Carley; Seyedroudbari, Ameen; Thin, Pan; Hoogland, Aasha I; Nguyen, Kathleen et al. · J Nucl Med · 2023

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Abstract

The field of radionuclide therapy (RNT) for prostate cancer (PC) is growing rapidly, with recent Food and Drug Administration approval of the first <sup>177</sup>Lu-PSMA ligand. We aimed to develop the first patient-reported outcome (PRO) measure for PC patients receiving RNT. <b>Methods:</b> We identified relevant symptoms and toxicities by reviewing published trials and interviews with PC patients receiving RNT (<i>n</i> = 29), caregivers (<i>n</i> = 14), and clinicians (<i>n</i> = 11). Second, we selected items for measure inclusion. Third, we refined the item list with input from experts in RNTs and PROs. Fourth, we finalized the Functional Assessment of Cancer Therapy-Radionuclide Therapy (FACT-RNT) with patient input. <b>Results:</b> This multistep process yielded a brief 15-item measure deemed by key stakeholders to be relevant and useful in the context of RNT for PC. <b>Conclusion:</b> The FACT-RNT is a new standardized tool to monitor relevant symptoms and toxicities among PC patients in RNT trials and real-world settings.

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