Developing a novel patient reported outcomes measure for prostate cancer patients receiving radionuclide therapy.

The field of radionuclide therapy (RNT) for prostate cancer (PC) is growing rapidly with recent FDA approval of the first Lutetium-177-PSMA-ligand. Current patient-reported outcomes (PRO) measures were designed to assess impacts of chemotherapy or surgery. We aimed to develop the first PRO measure for PC patients receiving RNT. Methods: First, we identified relevant symptoms/toxicities by reviewing published trials and interviews with PC patients receiving RNT ( n = 29), caregivers ( n = 14), and clinicians ( n = 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 FACT-RNT with patient input. Results: This multi-step process yielded a brief 15-item measure deemed by key stakeholders to be relevant and useful in the context of RNT for PC. Conclusion: The Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT) is a new standardized tool to monitor relevant symptoms/toxicities in RNT trials and real-world settings.