Research protocol to identify progression and death amongst patients with metastatic hormone-sensitive prostate cancer treated with available treatments: PIONEER IMI's "big data for better outcomes" program.

Androgen deprivation therapy-based with or without first-generation anti-androgens, was the standard of care for patients with metastatic hormone-sensitive prostate cancer (mHSPC) for decades. However, the development of docetaxel chemotherapy and new androgen receptor-targeted agents, abiraterone acetate and prednisolone, apalutamide , enzalutamide and darolutamide (in combination with docetaxel chemotherapy) has proven that combination of treatments is more effective. Recently, intensification therapy, so-called "triplets", have emerged in the armamentarium of mHSPC treatment. Metastatic disease is a clinical state that remains poorly understood. The optimal diagnostic and management of patients with mHSPC are changing thanks to the development of new imaging techniques and therapies. The primary objective of this study is to develop and validate a predictive model for the occurrence of symptomatic progression, initiation of new treatments and death amongst patients with mHSPC treated with one of the approved treatment plans, on characteristics present at admission.

International journal of surgery protocols. 2023 Oct 17*** epublish ***

Juan Gomez Rivas, Rossella Nicoletti, Laura Ibáñez, Carl Steinbeisser, Bertrand de Meulder, Asieh Golozar, Susan Evans Axelsson, Robert Snijder, Anders Bjartell, Philip Cornford, Mieke Van Hemelrijck, Katharina Beyer, Peter-Paul Willemse, Teemu Murtola, Monique J Roobol, Jesús Moreno-Sierra, Riccardo Campi, Mauro Gacci, Nicolas Mottet, Axel Merseburger, James Ndow

Department of Urology, Hospital Clínico San Carlos, Madrid, Spain., Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy., Steinbeisser Project Management, Munich., European Institute for Systems Biology and Medicine, CIRI UMR5308, CNRS-ENS-UCBL-INSERM, Lyon., Regeneron Pharmaceuticals, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA., Medical advisor, Lund University, Stockholm, Sweden., Astella Pharma, Tokyo, Japan., Liverpool University Hospitals NHS Trust, Liverpool, UK., Research, King's College London, London, UK., Department of Urology, Cancer Center University Medical Center Utrecht, Utrecht., Department of Urology, Tampere University Hospital, Tampere, Finland; Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland., Erasmus MC, Rotterdam, The Netherlands., Department of Urology, Hospitalier Universitaire de Saint-Étienne, Saint-Étienne, France., University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany., Department of Urology, University of Aberdeen, Aberdeen, Scotland.