Prostate-specific membrane antigen (PSMA)-PET usage in patients with prostate cancer is growing rapidly. Thus, novel risk-group definitions based on PSMA-PET are urgently needed for guidelines, clinical use, and trial study design. We report improved risk classification based on PSMA-PET Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE; PPP) nomograms (PPP3) to prognosticate 3-year, 5-year, and 7-year overall survival.
In this international, retrospective, registry-based cohort study, we collected data from the PROMISE PET registry with ongoing overall survival follow-up. Male patients (aged ≥18 years) with histological proven prostate cancer at any disease stage and any performance status, who underwent any PSMA-PET between Dec 6, 2012, and June 26, 2024, were included in the registry. Patients with neuroendocrine pattern or metastasised or disseminated malignancy other than prostate cancer were excluded. 35 investigator sites in Europe, Asia, Australia, North America, and South America were split pairwise (2:1) into development and validation cohorts. Entire investigator sites were split pairwise according to their site characteristics (ie, number of patients per disease group, country, follow-up). The primary study objective was overall survival. PPP3 nomograms were created based on Cox regression models with least absolute shrinkage and selection operator penalty to prognosticate 3-year, 5-year, and 7-year overall survival. Calibration curves and Harrell's c indices were applied and head-to-head comparison with clinical risk scores separated for each disease subgroup was conducted. Based on the visual PPP3 nomogram, a simplified risk-stratification table was created.
We analysed 11 154 patients and 7253 were included in the development cohort and 3901 in the validation cohort. Median follow-up to censoring or death was 4·9 years (IQR 3·5-6·6). Clinical disease group and PROMISE metrics were combined into visual and quantitative PPP3 nomograms, respectively. C indices were 0·83 (95% CI 0·82-0·84) for the visual nomogram and 0·84 (0·82-0·85) for the quantitative nomogram. Both nomograms and the simplified risk stratification table were accurate and equal or superior compared with established clinical risk scores (International Staging Collaboration for Cancer of the Prostate, European Association of Urology, a nomogram defined by Gafita and colleagues, and National Comprehensive Cancer Network).
We present new risk nomograms by PROMISE along with a simple table to prognosticate 3-year, 5-year, and 7-year overall survival in prostate cancer. PROMISE and PPP3 assessments are freely available online for global implementation.
German Research Foundation, Prostate Cancer Foundation, Innovative Health Initiative Joint Undertaking, Novartis, AstraZeneca, and Amgen.
The Lancet. Oncology. 2026 Mar 09 [Epub]
Madeleine J Karpinski, Caner Civan, Isabel Rauscher, Osman Güven, Matthias Eiber, Sebastian Hoberück, Matthias Miederer, Ralph A Bundschuh, Tobias Hölscher, Jeremie Calais, Lela Theus, Andrew T Nguyen, Helen Scholtissek, Constantin Lapa, Andrea Di Giorgio, Andrea Farolfi, Dominic Ufton, Alexander Drzezga, Jolanta Kunikowska, Kacper Pełka, Laura Evangelista, Glenn Bauman, Göksel Alçın, Stephan Beintner-Skawran, Mohd Fazrin Mohd Rohani, Jonathan Miksch, Anika Hüsing, Claudia Kesch, Ken Herrmann, Martin Stuschke, Lale Umutlu, Andrei Gafita, Michael S Hofman, Thomas A Hope, Karolien Goffin, Felix Kind, Daniele A Pizzuto, Timo F W Soeterik, Halil Kömek, Louise Emmett, Andrej Vondrak, Tomas Pinter, Francesco Lanfranchi, Matteo Bauckneht, Lena M Unterrainer, Adrien Holzgreve, Anders Bjartell, Elin Trägårdh, Sazan Rasul, Marcin Miszczyk, Martin Bögemann, Nadir Rodriguez SantAnna Jauregui, Michael Schäfers, Kambiz Rahbar, Boris A Hadaschik, Wolfgang P Fendler, PROMISE Registry Group
Department of Nuclear Medicine, DKTK and NCT University Hospital Essen, Essen, Germany; Department of Nuclear Medicine, University Hospital Münster and West German Cancer Center, Münster, Germany; Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Department of Nuclear Medicine, DKTK and NCT University Hospital Essen, Essen, Germany; Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Department of Nuclear Medicine, School of Medicine and Health, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany., Department of Nuclear Medicine, School of Medicine and Health, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany; Bavaria Cancer Research Centre (BZKF) Munich, Munich, Germany., Department of Nuclear Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany., Department of Nuclear Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany; Department of Translational Imaging in Oncology, National Center for Tumour Diseases (NCT/UCC) Dresden, Faculty of Medicine and University Hospital Carl Gustav Carus, University of Technology Dresden (TUD), Dresden, Germany., Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany., Ahmanson Translational Theranostics Division, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA., Nuclear Medicine, Faculty of Medicine, University of Augsburg, Augsburg, Germany., Nuclear Medicine, Alma Mater Studiorum, University of Bologna, Bologna, Italy., Nuclear Medicine, IRCCS, Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy., Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Nuclear Medicine Department, Medical University of Warsaw, Warsaw, Poland., Division of Nuclear Medicine, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy., Department of Oncology, Western University, London, ON, Canada., Istanbul Training and Research Hospital, Clinic of Nuclear Medicine, Istanbul, Turkey., Department of Nuclear Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Department of Nuclear Medicine, Hospital Kuala Lumpur, Malaysia; Department of Nuclear Medicine, Institut Kanser Negara, Putrajaya, Malaysia., Department of Nuclear Medicine, University Hospital Ulm, Ulm, Germany; Department of Radiology, University Hospital Ulm, Ulm, Germany., Institute of Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Essen, Germany., Department of Urology, DKTK and NCT University Hospital Essen, Essen, Germany., Department of Nuclear Medicine, DKTK and NCT University Hospital Essen, Essen, Germany., Department of Radiotherapy, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany., Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany., Johns Hopkins University School of Medicine, The Russell H Morgan Department of Radiology, Baltimore, MD, USA., Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia., Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA., Nuclear medicine, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Nuclear Medicine & Molecular Imaging, Department of Imaging & Pathology, KU Leuven, Leuven, Belgium., Department of Nuclear Medicine, Medical Center, University of Freiburg, Freiburg, Germany., Direzione Scientifica GSTeP Radiopharmacy, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy., Department of Radiation Oncology, University Medical Center Utrecht, Netherlands; Department of Urology, St Antonius Hospital Utrecht, Utrecht, Netherlands., Department of Nuclear Medicine, University of Health Sciences, Gazi Yasargil Training and Research Hospital, Diyarbakır, Turkey., Department of Theranostics and Nuclear medicine, St Vincent's Hospital, Sydney, Australia., IZOTOPCENTRUM, Nuclear Medicine Department, Nitra, Slovakia., Department of Experimental Medicine (DIMES), University of Genova, Genova, Italy., Nuclear Medicine, Department of Health Sciences (DISSAL), University of Genova, Genova, Italy; IRCCS Ospedale Policlinico San Martino, Genova, Italy., Department of Nuclear Medicine, LMU University Hospital, LMU Munich, Munich, Germany., Ahmanson Translational Theranostics Division, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Department of Nuclear Medicine, LMU University Hospital, LMU Munich, Munich, Germany., Department of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden., Department of Translational Medicine, Lund University, Malmö, Sweden; Department of Clinical Physiology and Nuclear Medicine, Skåne University Hospital, Malmö, Sweden; Wallenberg Centre of Molecular Medicine, Lund University, Lund, Sweden., Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University Vienna, Vienna, Austria., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Collegium Medicum-Faculty of Medicine, WSB University, Dąbrowa Górnicza, Poland., Department of Urology, University Hospital Münster and West German Cancer Center, Münster, Germany., Department of Nuclear Medicine, University Hospital Münster and West German Cancer Center, Münster, Germany., Department of Nuclear Medicine, DKTK and NCT University Hospital Essen, Essen, Germany. 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