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PERSPECTIVE article

Front. Oncol.
Sec. Genitourinary Oncology
Volume 14 - 2024 | doi: 10.3389/fonc.2024.1494073
This article is part of the Research Topic The Need for Pragmatic Trials in Genitourinary Oncology View all 3 articles

The value of real world evidence and pragmatic trials in advanced prostate cancerinsights from the electronic Prostate Cancer Australian and Asian Database (ePAD)

Provisionally accepted
Angelyn Anton Angelyn Anton 1,2,3Kristina Zlatic Kristina Zlatic 4*Sophie O'haire Sophie O'haire 4*Ben Tran Ben Tran 4,5*
  • 1 Walter and Eliza Hall Institute of Medical Research, The University of Melbourne, Melbourne, Australia
  • 2 Eastern Health, Melbourne, Australia
  • 3 Monash University, Melbourne, Victoria, Australia
  • 4 Walter and Eliza Hall Institute of Medical Research, The University of Melbourne, Parkville, Victoria, Australia
  • 5 Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

The final, formatted version of the article will be published soon.

    Prostate cancer is a common malignancy with an increasing incidence in ageing populations. However, older patients with prostate cancer are often underrepresented in traditional clinical trials. The electronic Prostate Cancer Australian and Asian Database (ePAD) is a multi-centre, multi-national prospective clinical registry, that records real world data from a broader population. An analysis of the first 753 metastatic castration-resistant prostate cancer (mCRPC) patients within ePAD demonstrated that 43% were aged 75 years and older. Older patients were more likely to have comorbidities including ischemic heart disease, diabetes and stroke. Treatment outcomes were similar in all age groups. However, older patients receiving chemotherapy were more likely to stop treatment due to toxicity. Furthermore, in a smaller ePAD analysis involving additional chart reviews within 3 high volume centres, at least one relative or absolute contraindication to abiraterone was seen in 72% of our cohort and with enzalutamide in 14%. In total, 47% had potential clinically significant drug interactions with abiraterone and 67% with enzalutamide. Registry-based randomised controlled trials (RRCTs) are a novel trial methodology aiming to bridge the gap between retrospective registry analyses and traditional randomised controlled trials. We conducted the REAL-Pro study in advanced prostate cancer, comparing cognition, depression and falls risk between CRPC patients receiving abiraterone or enzalutamide. The study closed early due to slow recruitment and a changing treatment landscape, highlighting the need for further research to understand clinician and patient perspectives towards pragmatic trials such as RRCTs and subsequently develop strategies to optimise future trial design and recruitment.

    Keywords: prostate cancer, Real world data, registry trials, Pragmatic trials, Older patients'

    Received: 10 Sep 2024; Accepted: 31 Oct 2024.

    Copyright: © 2024 Anton, Zlatic, O'haire and Tran. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Kristina Zlatic, Walter and Eliza Hall Institute of Medical Research, The University of Melbourne, Parkville, VIC 3052, Victoria, Australia
    Sophie O'haire, Walter and Eliza Hall Institute of Medical Research, The University of Melbourne, Parkville, VIC 3052, Victoria, Australia
    Ben Tran, Walter and Eliza Hall Institute of Medical Research, The University of Melbourne, Parkville, VIC 3052, Victoria, Australia

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.