Diagnostic and Prognostic Factors in Patients with Prostate Cancer: A Systematic Review

Multiple biomarkers are available to improve the diagnosis and prognosis of prostate cancer (PCa); however, knowledge of which biomarkers can be used to select patients for a specific treatment remains unclear. One of the major challenges within the context of PCa diagnostic or prognostic biomarkers/factors (DPFs) is the inability to incorporate DPFs into the management of PCa in terms of screening, diagnosis and treatment. Overcoming this challenge is a key objective for PCa researchers; therefore, it is very important to summarise and evaluate the evidence for DPFs is a clear and unbiased way.

The PIONEER Consortium, an international collaboration coordinated by the European Association of Urology and Bayer and funded by the Innovative Medicine Initiative, aims to address evidence gaps in PCa care through the power of big data analytics to move towards a more outcome-driven, value-based and patient-centric healthcare system. As part of PIONEER we systematically reviewed the evidence from 2014 onwards to assess which DPFs are available in relation to previously defined outcomes for PCa.

With the help of a multidisciplinary team, we followed a four-step approach (Figure 1):

A comprehensive systematic review of diagnostic and prognostic factors for localised, locally advanced, metastatic, and non-metastatic castration resistant prostate cancer from 2014 onwards.
Assessment and review of the identified diagnostic and prognostic factors by a multidisciplinary expert panel.
Evaluation of the quality of the studies identified using risk of bias tools including PROBAST, QUIPS, and QUADAS-2.
Development of the PIONEER online search tool for prostate cancer diagnostic and prognostic factors.

Figure 1. PIONEER online search tool

We identified that at present DPFs that are capable of significantly improving diagnosis and prognosis in PCa are an unmet need. Most of the DPFs identified require additional evaluation and validation in properly designed studies before they can be recommended for use in clinical practice. Well-designed real-world evidence studies can help to increase quality. Our systematic review aims to inform clinicians and patients about this rapidly evolving field. In addition, we created the PIONEER online search tool for PCa DPFs which enables researchers to perform future research, and understand the quality of the currently available studies.

PIONEER is funded through the IMI2 Joint Undertaking and is listed under grant agreement 777492. The views communicated within are those of PIONEER. Neither the IMI nor the European Union, EFPIA, or any Associated Partners is responsible for any use that may be made of the information contained herein.

Written by: Katharina Beyer,¹ Lisa Moris,² Michael Lardas,³ Anna Hairea,⁴ Francesco Barletta,⁴ Simone Scuderi,⁴ Megan Molnar,⁵ Ronald Herrera,⁵ Abdul Rauf,⁶ Riccardo Campi,⁷ Isabella Greco,⁷ Kirill Shiranov,⁸ Saeed Dabestani,⁹ Thomas van den Broeck,² Sujenthiran Arun,¹⁰ Mauro Gacci,⁷ Giorgio Gandaglia,⁴ Muhammad Imran Omar,¹¹ Steven MacLennan,¹¹ Monique J. Roobol,¹² Bahman Farahmand,¹³ Eleni Vradi,⁵ Zsuzsanna Devecseri,¹⁴ Alex Asiimwe,⁵ Jihong Zong,¹⁵ Sara J MacLennan,¹¹ Laurence Collette,¹⁶ James N’Dow,¹² Alberto Briganti,^4,17 Anders Bjartell,¹⁸ Mieke Van Hemelrijck¹ and the PIONEER Consortium

Translational and Oncology Research (TOUR), King’s College London, Faculty of Life Sciences and Medicine, London, UK
Department of Urology, University Hospitals Leuven, Leuven, Belgium
Department of Urology, Metropolitan general, Athens, Greece
Unit of Urology/Division of Oncology, URI, IRCCS Ospedale San Raffaele, Milan, Italy
Department of Epidemiology, Bayer AG, Berlin, Germany
Department of Urology, Mid Cheshire Hospitals, NHS Foundation Trust, Crewe CW1 4QJ, United Kingdom
Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Florence, Italy
CDC “Zdorovie “, Rostov-on-Don, Russia
Dept. of Translational Medicine, Division of Urological Cancers, Lund University, Kristianstad Central Hospital, Malmo, Sweden.
Department of Urology, St George’s NHS Foundation Trust, London
Academic Urology Unit, University of Aberdeen, Aberdeen, UK
Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Global Epidemiology, Bayer AB, Stockholm, Sweden
Sanofi, France
Global Medical Affairs Oncology, Real World Evidence, Bayer HealthCare Pharmaceuticals Inc., Whippany, New Jersey, USA
EORTC Headquarters, Brussels, Belgium
Department of Urology, University Vita e Salute-San Raffaele, Milan, Italy
Department of Translational Medicine, Lund University, Malmö, Sweden

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