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.
Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2023 Jan 12 [Epub ahead of print]
Lisa M Gudenkauf, Melody Chavez, Melinda L Maconi, Carley Geiss, Ameen Seyedroudbari, Pan Thin, Aasha I Hoogland, Kathleen Nguyen, Vishnu Murthy, Wesley R Armstrong, Khaled Komrokji, Laura B Oswald, Heather S L Jim, Ghassan El-Haddad, Wolfgang Peter Fendler, Ken Herrmann, David Cella, Johannes Czernin, Michael S Hofman, Adam P Dicker, Jeremie Calais, Scott T Tagawa, Brian D Gonzalez
Moffitt Cancer Center, United States., UCLA., Essen University Hospital., Northwestern University, United States., UCLA School of Medicine., Peter MacCallum Cancer Centre., Thomas Jefferson University, United States., Cornell University - Weill Cornell Medical College.