PIONEER

Prostate cancer diagnosis and treatment enhancement through the power of big data in Europe

Summary

Out of all the 2.7 million new cases of cancer diagnosed per year in the European Union, 12.1% are prostate cancer, making it the fourth most common cancer in the world.

Although prostate cancer is highly prevalent, we still know relatively little about who is most likely to develop it and which risk factors play the biggest role. PIONEER leveraged real-world data to stratify the patient population and to identify some shared characteristics of prostate cancer patients. This will speed up the diagnosis of prostate cancer and improve care for patients.

Every day around the world, data on prostate cancer patients is collected from registries, electronic health records, epidemiological cohorts and clinical trials, but it is stored in inconsistent formats. PIONEER has harmonised data on 3.5 million prostate cancer patients and it is available for use in the PIONEER platform. By applying big data analytics and a common data model framework, PIONEER transformed these heterogeneous real-world data into high-quality real-world evidence that  researchers can trust and use reliably.

PIONEER experimented with innovative ways of working, organising three international study-a-thons. The first was held virtually during the COVID-19 pandemic, followed by two successful hybrid events.  Each study-a-thon brought together clinicians, researchers, data scientists, patients and other stakeholders to tackle various research questions across 5 days. Several peer-reviewed publications arose as a result of these events.

Through interviews and other forms of engagement with patients, the researchers discovered that a cure wasn’t necessarily the only outcome that interested men with prostate cancer. Many wanted to be able to avoid treatment-related side effects, especially since prostate cancer doesn’t always present with symptoms and  curative therapies sometimes pose greater risk than the disease itself. To address this, PIONEER analysed data from over 500 000 patients to pinpoint when active intervention is warranted and when ‘conservative management’– monitoring the disease without immediate treatment – is preferable.

PIONEER used big data to sift through the existing information available about prostate cancer patients, their characteristics and their responses to treatment. With this, they were able to identify several factors that could indicate a person’s suitability either for treatment or for taking the conservative approach.

PIONEER delivered a clear picture of the profile of the patient who is likely to benefit from prostate cancer treatment, taking into account age, hypertension, obesity and type 2 diabetes, amongst other factors. They found that the typical profile of a patient in the real world differed substantially from those enrolled in clinical trials. For instance, the typical patient that could benefit from treatment is over the age of 68 and has several comorbidities, especially heart issues and type 2 diabetes. In contrast, most clinical trials for prostate cancer treatments enroll patients younger than 65 with few serious health issues.

The PIONEER study showed that strict exclusion criteria in randomised clinical trials limited the applicability of their findings.  Clinicians should account for these limitations when applying trial results to patient care. The study further recommends that future randomised clinical trials adopt broader enrollment criteria to better serve the most needy patients.

To ensure that interventions and treatments are effective and safe, researchers need to look at the effects they have on patients. Researchers do this by measuring ‘outcomes’, which are variables measured during clinical trials that demonstrate whether an intervention or treatment was effective.

For example, in a study of how well a prostate cancer treatment works outcomes might include: overall survival; progression free survival; sexual, bowel and urinary function. A core outcome set is an agreed standardised group of outcomes that researchers should measure and report if they are conducting a clinical trial in a particular disease area.

PIONEER developed Core Outcome Sets that can be used to measure outcomes in prostate cancer patients. The Core Outcome Sets are the result of a methodological rigorous systematic review and consensus finding process with a diverse range of prostate cancer stakeholders including clinicians, nurses, researchers, industry partners and most importantly patients, and they have been endorsed by the European Association of Urology, Europe’s leading medical authority on urological practice, research and education.

While measuring core outcomes is important, it is also critical to evaluate the impact of side effects and health-related quality of life on patients with prostate cancer. It is especially important because prostate cancer patients may have to choose between health-related quality of life or length of life.

PIONEER systematically reviewed both clinician reported outcomes and Patient Reported Outcome Measures (PROMs) used in localised, locally advanced, and metastatic prostate cancer. Based on the results of the reviews and subsequent consensus processes, PIONEER recommended minimum sets of clinician and patient reported outcomes, provided definitions or each, and recommended PROMs, for use in routine practice and research settings.

PIONEER also developed an online search tool to help clinicians choose which biomarkers they want to use to determine a course of treatment for a patient with prostate cancer.

Achievements & News

First batch of real-world data from prostate cancer studies added to big data platform

The first two datasets have been added to the PIONEER big data platform, a major milestone for the IMI project. The researchers want to use real-world data from well-known prostate cancer studies to answer some vital questions about the disease. ###The first question they hope the data will help answer concerns the kind of variables that affect the prognosis for prostate cancer patients.

The two datasets will be followed by more; other partners are poised to add another 22 anonymised datasets to the platform, and PIONEER hopes that other data custodians, both private and public, will be encouraged to contribute. The ultimate aim is to improve the health and social care for all prostate cancer patients and their families.

Analytics will be run over the lifetime of the project to account for new and updated datasets. Both the OMOP/OHDSI platform for population-based registries and epidemiological research and the PIONEER omics analysis platform for cohort and clinical trial data were set up by The Hyve, a partner in the project.

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Participants

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Universities, research organisations, public bodies, non-profit groups
  • Association Eisbm, Vourles, France
  • Astellas Pharma Europe BV, Leiden, Netherlands
  • Astrazeneca AB, Sodertaelje, Sweden
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
  • European Alliance for Personalised Medicine, Maribor, Slovenia
  • European Cancer Patient Coalition, Bruxelles / Brussel, Belgium
  • European Organisation For Research And Treatment Of Cancer Aisbl, Bruxelles / Brussel, Belgium
  • Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., Munchen, Germany
  • Goeteborgs Universitet, Goeteborg, Sweden
  • Helmholtz-Zentrum Dresden-Rossendorf Ev, Dresden, Germany
  • Imperial College Of Science Technology And Medicine, London, United Kingdom
  • Ims Information Solutions Medical Research Limited, London, United Kingdom
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • King'S College London, London, United Kingdom
  • Labcorp Early Development Laboratories Limited, Harrogate, United Kingdom
  • Lunds Universitet, Lund, Sweden
  • Nv SAS Institute SA, Tervuren, Belgium
  • Orion Oyj, Espoo, Finland
  • PNO Life Sciences & Health B.V., Rijswijk, Netherlands
  • Pinsent Masons Llp, London, United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Gentilly, France
  • Stichting Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
  • Tampereen Korkeakoulusaatio Sr, Tampere, Finland
  • Technische Universitaet Dresden, Dresden, Germany
  • The University Court Of The University Of Aberdeen, Aberdeen, United Kingdom
  • Universita Vita-Salute San Raffaele, Milano, Italy
  • Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany
  • Weizmann Institute Of Science, Rehovot, Israel
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Ihe, Institutet For Halso- Och Sjukvardsekonomi Aktiebolag, Lund, Sweden
  • International Consortium For Healthoutcomes Measurement LTD, Erith, United Kingdom
  • Stichting European Urological Foundation, Arnhem, Netherlands
  • The Ecancer Global Foundation, Bristol, United Kingdom
  • The Hyve BV, Utrecht, Netherlands

Participants
NameEU funding in €
Association Eisbm758 200
Cancer Intelligence Limited (left the project)12 121
Erasmus Universitair Medisch Centrum Rotterdam415 349
European Alliance for Personalised Medicine180 000
European Cancer Patient Coalition69 994
European Organisation For Research And Treatment Of Cancer Aisbl16 000
Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.125 000
Goeteborgs Universitet150 650
Helmholtz-Zentrum Dresden-Rossendorf Ev101 300
Ihe, Institutet For Halso- Och Sjukvardsekonomi Aktiebolag175 000
Imperial College Of Science Technology And Medicine200 000
International Consortium For Healthoutcomes Measurement LTD31 250
King'S College London359 000
Lunds Universitet185 761
Pinsent Masons Llp188 800
PNO Life Sciences & Health B.V.237 500
Stichting European Urological Foundation797 439
Stichting Radboud Universitair Medisch Centrum124 922
Stichting Radboud Universiteit (left the project)25 078
Tampereen Korkeakoulusaatio Sr212 500
Technische Universitaet Dresden125 000
The Ecancer Global Foundation37 333
The Hyve BV400 000
The University Court Of The University Of Aberdeen409 303
Universita Vita-Salute San Raffaele312 500
Universitaetsklinikum Hamburg-Eppendorf150 000
Weizmann Institute Of Science200 000
Total Cost6 000 000