Clinical Characterization of Patients Diagnosed with Prostate Cancer and Undergoing Conservative Management: A PIONEER Analysis Based on Big Data.

Conservative management is an option for prostate cancer (PCa) patients either with the objective of delaying or even avoiding curative therapy, or to wait until palliative treatment is needed. PIONEER, funded by the European Commission Innovative Medicines Initiative, aims at improving PCa care across Europe through the application of big data analytics.

To describe the clinical characteristics and long-term outcomes of PCa patients on conservative management by using an international large network of real-world data.

From an initial cohort of >100 000 000 adult individuals included in eight databases evaluated during a virtual study-a-thon hosted by PIONEER, we identified newly diagnosed PCa cases (n = 527 311). Among those, we selected patients who did not receive curative or palliative treatment within 6 mo from diagnosis (n = 123 146).

Patient and disease characteristics were reported. The number of patients who experienced the main study outcomes was quantified for each stratum and the overall cohort. Kaplan-Meier analyses were used to estimate the distribution of time to event data.

The most common comorbidities were hypertension (35-73%), obesity (9.2-54%), and type 2 diabetes (11-28%). The rate of PCa-related symptomatic progression ranged between 2.6% and 6.2%. Hospitalization (12-25%) and emergency department visits (10-14%) were common events during the 1st year of follow-up. The probability of being free from both palliative and curative treatments decreased during follow-up. Limitations include a lack of information on patients and disease characteristics and on treatment intent.

Our results allow us to better understand the current landscape of patients with PCa managed with conservative treatment. PIONEER offers a unique opportunity to characterize the baseline features and outcomes of PCa patients managed conservatively using real-world data.

Up to 25% of men with prostate cancer (PCa) managed conservatively experienced hospitalization and emergency department visits within the 1st year after diagnosis; 6% experienced PCa-related symptoms. The probability of receiving therapies for PCa decreased according to time elapsed after the diagnosis.

European urology. 2023 Jul 04 [Epub ahead of print]

Giorgio Gandaglia, Francesco Pellegrino, Asieh Golozar, Bertrand De Meulder, Thomas Abbott, Ariel Achtman, Muhammad Imran Omar, Thamir Alshammari, Carlos Areia, Alex Asiimwe, Katharina Beyer, Anders Bjartell, Riccardo Campi, Philip Cornford, Thomas Falconer, Qi Feng, Mengchun Gong, Ronald Herrera, Nigel Hughes, Tim Hulsen, Adam Kinnaird, Lana Y H Lai, Gianluca Maresca, Nicolas Mottet, Marek Oja, Peter Prinsen, Christian Reich, Sebastiaan Remmers, Monique J Roobol, Vasileios Sakalis, Sarah Seager, Emma J Smith, Robert Snijder, Carl Steinbeisser, Nicolas H Thurin, Ayman Hijazy, Kees van Bochove, Roderick C N Van den Bergh, Mieke Van Hemelrijck, Peter-Paul Willemse, Andrew E Williams, Nazanin Zounemat Kermani, Susan Evans-Axelsson, Alberto Briganti, James N'Dow, PIONEER Consortium

Guidelines Office, European Association of Urology, Arnhem, The Netherlands; Department of Urology and Division of Experimental Oncology, Urological Research Institute, IRCCS San Raffaele Hospital, Milan, Italy. Electronic address: ., Department of Urology and Division of Experimental Oncology, Urological Research Institute, IRCCS San Raffaele Hospital, Milan, Italy., Odysseus Data Services, New York, NY, USA; OHDSI Center, Northeastern University, Boston, MA, USA., Association EISBM, Vourles, France., Astellas Pharma, Inc., Northbrook, IL, USA., The Movember Foundation, Melbourne, Australia., Guidelines Office, European Association of Urology, Arnhem, The Netherlands; Academic Urology Unit, University of Aberdeen, Scotland, UK., Riyadh Elm University, Riyadh, Saudi Arabia., University of Oxford, Oxford, UK., Bayer AG, Berlin, Germany., Translational Oncology and Urology Research, King's College London, London, UK., Department of Translational Medicine, Lund University, Lund, Sweden., Guidelines Office, European Association of Urology, Arnhem, The Netherlands; Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy., Liverpool University Hospitals, Liverpool, UK., Department of Biomedical Informatics, Columbia University, New York, NY, USA., Nanfang Hospital, Southern Medical University, Guangzhou, China; DHC Technologies, Beijing, China., Epidemiology, Janssen R&D, Belgium., Philips Research, Department of Hospital Services & Informatics, Eindhoven, The Netherlands., University of Alberta, Edmonton, Canada., University of Manchester, Manchester, UK., Department of Urology, NHS Grampian, Scotland, UK., Guidelines Office, European Association of Urology, Arnhem, The Netherlands., Institute of Computer Science, University of Tartu, Tartu, Estonia; STACC, Tartu, Estonia., Netherlands Comprehensive Cancer Organization, Eindhoven, The Netherlands., IQVIA, London, UK., Erasmus University Medical Centre, Cancer Institute, Rotterdam, The Netherlands., Department of Urology, General Hospital of Thessaloniki Agios Pavlos, Thessaloniki, Greece., RWS, IQVIA, Durham, NC, USA., INSERM CIC-P 1401, Bordeaux PharmacoEpi, Université de Bordeaux, Bordeaux, France., The Hyve, Utrecht, The Netherlands., St Antonius Hospital, Utrecht, The Netherlands., Guidelines Office, European Association of Urology, Arnhem, The Netherlands; Department of Urology, Cancer Center, University Medical Center Utrecht, Utrecht, The Netherlands., The Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, Boston, MA, USA., Department of Computing, Data Science Institute, Imperial College London, London, England., Guidelines Office, European Association of Urology, Arnhem, The Netherlands; Department of Urology and Division of Experimental Oncology, Urological Research Institute, IRCCS San Raffaele Hospital, Milan, Italy.