Metastatic prostate cancer (PCa) constitutes ~5% of all new PCa diagnoses in Western countries. For most cases, primary consideration should be given to systemic therapies as the first-line approach based on evidence from randomized controlled trials (RCTs). Despite the importance of RCTs as the pinnacle of evidence in modern medicine, concerns have been raised about their applicability to real-life scenarios. These trials often feature participants who are younger with better performance statuses and prognoses compared to their real-world counterparts. The PIONEER project falls under the Innovative Medicine Initiative's (IMI) "Big Data for Better Outcomes" initiative, aimed at revolutionizing PCa care in Europe. The central focus lies in improving cancer-related outcomes, enhancing health system efficiency, and elevating the quality of health and social care. This study endeavours to evaluate the generalizability of RCT findings concerning newly diagnosed metastatic PCa.
A systematic review of the literature will be conducted to compile patient characteristics from RCTs addressing this subject within the past decade. To create a real-world benchmark, patients with recently diagnosed metastatic PCa from a network of population-based databases will serve as a comparison group. The objective is to assess the applicability of RCT results in two ways. First, a comparison will be made between the characteristics of patients with newly diagnosed metastatic PCa enroled in RCTs and those with the same condition included in our databases which might represent the real-world setting. Second, an evaluation will be undertaken to determine the proportion of real-world patients with newly diagnosed metastatic PCa who meet the criteria for RCT enrolment. This study will rely on extensive observational data, primarily sourced from population-based registries, electronic health records, and insurance claims data. The study cohort is established upon routinely gathered healthcare data, meticulously mapped to the Observational Medical Outcomes Partnership Common Data Model.
International journal of surgery protocols. 2024 Apr 15*** epublish ***
Giorgio Gandaglia, Francesco Pellegrino, Bertrand De Meulder, Ayman Hijazy, Thomas Abbott, Asieh Golozar, Rossella Nicoletti, Juan Gomez-Rivas, Carl Steinbeisser, Susan Evans-Axelsson, Alberto Briganti, James N'Dow
Division of Oncology/Unit of Urology, Soldera Prostate Cancer Lab, URI, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan., Association EISBM, Vourles, France., Astellas Pharma, Inc., Northbrook, IL., OHDSI Center, Northeastern University, Boston, MA., Department of Experimental and Clinical Biomedical Science, University of Florence, Florence, Italy., Department of Urology, Hospital Clínico San Carlos, Madrid, Spain., Collaborate Project Management, Munich., Bayer AG, Berlin, Germany., Academic Urology Unit, University of Aberdeen, Scotland, UK.