Prostate cancer risk groups by PSMA-PET PROMISE (PPP): Results from an international multi-center registry study.
Abstract
266 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).
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (20)
Wolfgang Peter Fendler
Madeleine J. Karpinski
Department of Nuclear Medicine, University of Duisburg-Essen, and German Cancer Consortium (DKTK), NCT, University Hospital Essen, Essen, Germany
Sebastian Hoberück
Department of Nuclear Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany
Isabel Rauscher
Lena Unterrainer
Department of Nuclear Medicine, LMU University Hospital, LMU Munich, Munich, Germany
Sazan Rasul
Medical University of Vienna, Vienna, Austria
Anders Bjartell
Skåne University Hospital, Department of Urology, Malmö, Sweden
Francesco Lanfranchi
Andrea Di Giorgio
Nuclear Medicine, Alma Mater Studiorum University of Bologna, Bologna, Italy
Christian Helmut Pfob
Nuclear Medicine, Faculty of Medicine, University of Augsburg, Augsburg, Germany
Timo Soeterik
Department of Urology, St Antonius Ziekenhuis Nieuwegein/Utrecht, The Netherlands, Utrecht, Netherlands
Karolien Goffin
Department of Nuclear Medicine, Division of Nuclear Medicine and Molecular Imaging, University Hospital Leuven, KU Leuven, Leuven, Belgium
Felix Kind
Department of Nuclear Medicine, Medical Center, University of Freiburg, Freiburg, Germany
Jonathan Miksch
Department of Nuclear Medicine, University Hospital Ulm, Ulm, Germany
Jeremie Calais
Luca F. Valle, MD, Department of Radiation Oncology, University of California Los Angeles, Los Angeles, CA, Radiation Oncology Service, Greater Los Angeles VA Healthcare System, Los Angeles, CA, University of California Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA, Jeremie Calais, MD, PhD, University of California Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA, Department of Nuclear Medicine, University of California Los Angeles, Los Angeles, CA, Amar U. Kishan, MD, Department of Radiation Oncology, University of California Los Angeles, Los Angeles, CA, University of California Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA
Michael S. Hofman
Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
Thomas A. Hope
Irbaz Bin Riaz, MD, PhD; R. Bryan Rumble, MSc; Thomas A. Hope, MD; Giuseppe Procopio, MD; and Neha Vapiwala, MD; Mayo Clinic, Phoenix, AZ; American Society of Clinical Oncology, Alexandria, VA; University of California, San Francisco, San Francisco, CA; Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy; and University of Pennsylvania Abramson Cancer Center, Philadelphia, PA
Ken Herrmann
Boris A. Hadaschik
University of Duisburg-Essen, Essen, Germany
Kambiz Rahbar