We investigated the prognostic value of baseline [18F]FDG and [68Ga]Ga-PSMA-11 PET/CT in patients with metastatic castration-resistant prostate cancer treated with [177Lu]Lu-PSMA-617. Methods: In this multicenter retrospective study, the associations between several clinical, biologic, and radiologic parameters and overall survival (OS) were tested in a development cohort using univariable analyses, followed by the construction of a multivariable Cox model. The PROFILE prognostic score was subsequently derived from this model, internally validated, and externally validated in an independent cohort. Results: Data from 174 patients from 3 centers were used to construct the multivariable Cox model. Five independent adverse prognostic factors were identified and incorporated into the PROFILE score: an SUVmax exceeding 300% of the PERCIST threshold on [18F]FDG PET/CT, a "nonhigh" classification on [68Ga]Ga-PSMA-11 PET/CT using the visual PSMA tumor-to-salivary gland ratio, a baseline hemoglobin level of 11 g/dL or less, a baseline alkaline phosphatase level of greater than 220 IU/L, and a disease duration not exceeding 100 mo. The PROFILE score stratified patients into 3 risk groups and achieved a Harrell C-index of 0.67 (95% CI, 0.62-0.72). The median OS in the low-, intermediate-, and high-risk groups was 17.2, 13.0, and 8.6 mo, respectively (P < 0.0001). These results were confirmed in 114 patients in an independent, single-center validation cohort, with median OS of 20.4, 14.3, and 8.8 mo (P < 0.0001), respectively, and a C-index of 0.73 (95% CI, 0.68-0.78). Conclusion: The PROFILE score offers valuable prognostic information for patients with metastatic castration-resistant prostate cancer when considering the use of [177Lu]Lu-PSMA-617 therapy.
Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2026 Jul 16 [Epub ahead of print]
Adrien Jougla, Prescillia Nunes, Anne-Laure Giraudet, Anaïs Olivier, Julie Blanc, Alexandre Cochet, Sylvain Ladoire, Jean-Marc Vrigneaud, Lavinia Vija-Racaru, Clément Drouet
Department of Nuclear Medicine, Université Bourgogne Europe, Centre Georges-François Leclerc, Dijon, France., Department of Statistics, Université Bourgogne Europe, Centre Georges-François Leclerc, Dijon, France., Department of Nuclear Medicine, Centre Léon Bérard, Lyon, France., Department of Nuclear Medicine, Centre Oscar Lambret, Lille, France., Department of Nuclear Medicine, ICMUB, UMR CNRS 6302, Université Bourgogne Europe, Centre Georges-François Leclerc, Dijon, France., Centre Georges-François Leclerc, Department of Medical Oncology, Université Bourgogne Europe, Dijon, France., Department of Nuclear Medicine, IMATHERA UMS INSERM BioSanD US58, Université Bourgogne Europe, Centre Georges-François Leclerc, Dijon, France; and., Department of Nuclear Medicine, Oncopole Claudius Regaud, Toulouse, France., Department of Nuclear Medicine, Université Bourgogne Europe, Centre Georges-François Leclerc, Dijon, France; .