Prostate cancer risk groups by PSMA-PET PROMISE (PPP): Results from an international multi-center registry study.

• DOI: 10.1200/jco.2025.43.5_suppl.266
• Publication Date: 2025-02-18T14:43:07Z
• Authors: Wolfgang Peter Fe...; Madeleine J. Karp...; Sebastian Hoberück; Isabel Rauscher; Lena Unterrainer; Sazan Rasul; Anders Bjartell; Francesco Lanfranchi; Andrea Di Giorgio; Christian Helmut ...; Timo Soeterik; Karolien Goffin; Felix Kind; Jonathan Miksch; Jeremie Calais; Michael S. Hofman; Thomas A. Hope; Ken Herrmann; Boris A. Hadaschik; Kambiz Rahbar

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Background: We previously established prognostic nomograms of PSMA-PET standardized by Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria in a large single-center cohort. Now, we reassess the PSMA-PET PROMISE (PPP) prognostic nomograms in a large international multi-center registry study with overall survival follow-up. Methods: We included patients with histologically proven prostate cancer who underwent PSMA-PET at 20 hospitals in Germany, Italy, Sweden, Netherlands, Belgium, Slovakia, Austria, United States and Australia between 2014 and 2021. PSMA-PET was standardized by molecular imaging TNM (miTNM). Total tumor volume in L, PSMA expression score and overall survival follow-up were obtained. The cohort was randomly split 2:1 into development and validation cohorts. In the development cohort we assessed PPP predictors and created visual and quantitative PPP nomograms based on Cox regression models with least absolute shrinkage and selection operator penalty for overall survival. Performance of both nomograms was measured in the validation cohort using Harrell´s C-index and calibration plots. Head-to-head comparison to the NCCN risk score was examined by ROC-curves. Results: We analyzed 6128 male patients (4075 development and 2053 validation) across all disease stages with 1915 (31.2%) reported deaths and median follow-up of 4.77 years [IQR 3.38-6.44]. Predictors in the visual PPP nomogram were distant metastases (extrapelvic nodal metastases [M1a], bone metastases [M1b; oligometastatic disease, disseminated or diffuse marrow involvement], and organ metastases [M1c]), PSMA expression score and total tumor lesion count. Predictors in the reassessed quantitative PPP nomogram were distant metastases (M1a, M1b, and M1c), tumor volume and PSMA expression score. C-indices (95% CI) in the validation cohort were 0.812 (0.794; 0.830) for the visual and 0.821 (0.805; 0.837) for the quantitative nomogram, respectively. For three-tier stratification (high, intermediate, low risk), accuracy of both PPP nomograms was superior when compared to the NCCN risk score (n=3638, visual: AUC 0.828 vs. 0.756; p<0.0001 and quantitative: AUC 0.837 vs. 0.756; p<0.0001). Conclusions: PSMA-PET PROMISE nomograms in an international multi-center study accurately stratify high vs. intermediate vs. low-risk groups for overall survival across all stages of prostate cancer and yield superior accuracy compared to the NCCN risk score. Follow-up continues in the PROMISE Registry (NCT06320223, promise-pet.org).