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The challenging landscape of medical device approval in localized prostate cancer

Nature Reviews Urology volume 13, pages 91–98 (2016)Cite this article

Subjects

Key Points

  • The ability of modern multiparametric MRI to detect clinically significant prostate cancer has provided clinicians with relevant targets to be sampled and ablated using novel image-guided medical devices

  • Compared with the standardized pathways for evaluation of pharmaceutical agents, medical devices follow a less structured pathway to approval, and many key differences exist between Europe and the USA

  • European residents benefit from earlier adoption of new technologies; however, European device regulatory pathways have been criticised for allowing new devices to be used on patients without robust evaluation

  • By contrast, the regulatory pathway in the USA is more rigid, and the manner in which 'grandfathering' of similar devices can occur seems too heavily weighted against the introduction of novel medical devices

  • In this article, we discuss these issues and offer some perspective on the potentially safe, effective and compliant evaluation of novel image-guided devices for use in patients with prostate cancer

Abstract

Findings of research using modern multiparametric MRI have provided clinicians with reliable targets for guiding prostate biopsy sampling and directing targeted therapy, often termed focal therapy, to specific areas of the prostate. This emerging shift in treatment strategy from a whole-gland approach to a lesion-specific or region-specific approach requires novel medical devices. The rules regulating the approval and clinical use of such new devices often differ between the USA and Europe, and these differences can affect the treatments that patients receive. Current regulatory pathways for approval of various image-guided biopsy and focal therapy devices intended to be used in patients with prostate cancer are discussed in detail. Finally, we offer some perspective on the current status of research in the field, and propose a potential roadmap towards the establishment of timely, safe and standardized criteria for optimal evaluation of novel image-guided devices for treatment of patients with localized prostate cancer.

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Figure 1: Regulatory pathways for the approval of new devices in Europe and the USA.

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Acknowledgements

M.V. gratefully acknowledges financial support from the SICPA foundation. M.E. and H.U.A. gratefully acknowledge financial support from the Medical Research Council (UK), the Pelican Cancer Foundation charity, Prostate Cancer UK, National Institute of Health Research-Health Technology Assessment and i4i programmes, St Peters Trust charity, Prostate Cancer Foundation, the Wellcome Trust and the US National Institute of Health-National Cancer Institute. M.E. also receives funding in part from the UK National Institute of Health Research UCLH/UCL Comprehensive Biomedical Research Centre. S.E.E. gratefully acknowledges funding from the US Department of Defense and National Cancer Institute. The authors would like to thank Mr Mark Duval and Mr Sew-Wah Tay for their comments on a previous draft of this manuscript.

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Authors and Affiliations

  1. Division of Surgery and Interventional Science, University College London, 21 University Street, WC1E 6AU, London, UK

    Massimo Valerio, Mark Emberton & Hashim U. Ahmed

  2. University of Chicago Medical Center, 5841 South Maryland Avenue, Chicago, 60637, Illinois, USA

    Scott E. Eggener

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Contributions

M.V. and H.U.A. researched data for this article. All authors made a substantial contribution to discussions of content, writing the manuscript and reviewing and/or editing of the manuscript before submission.

Corresponding author

Correspondence to Massimo Valerio.

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Competing interests

M.E. and H.U.A. have received funding for clinical trials from Advanced Medical Diagnostics, GSK, Hitachi, Immodulon, Sonacare, Sophiris Biocorp and Trod Medical and have previously acted as consultants for Oncura/GE Healthcare and Steba Biotech. M.E. is a consultant of Sonacare and Steba Biotech, has share options in Nuada Medical and is a director on the board of this company. S.E.E. has received research support from Myriad and is a consultant of Myriad, NxThera and Profound Medical. M.V. declares no competing interests.

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Valerio, M., Emberton, M., Eggener, S. et al. The challenging landscape of medical device approval in localized prostate cancer. Nat Rev Urol 13, 91–98 (2016). https://doi.org/10.1038/nrurol.2015.289

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