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INNOVATE: A prospective cohort study combining serum and urinary biomarkers with novel diffusion-weighted magnetic resonance imaging for the prediction and characterization of prostate cancer

Title: INNOVATE: A prospective cohort study combining serum and urinary biomarkers with novel diffusion-weighted magnetic resonance imaging for the prediction and characterization of prostate cancer
Authors: Johnston, E
Pye, H
Bonet-Carne, E
Panagiotaki, E
Patel, D
Galazi, M
Heavey, S
Carmona, L
Freeman, A
Trevisan, G
Allen, C
Kirkham, A
Burling, K
Stevens, N
Hawkes, D
Emberton, M
Moore, C
Ahmed, HU
Atkinson, D
Rodriguez-Justo, M
Ng, T
Alexander, D
Whitaker, H
Punwani, S
Item Type: Journal Article
Abstract: Background: Whilst multi-parametric magnetic resonance imaging (mp-MRI) has been a significant advance in the diagnosis of prostate cancer, scanning all patients with elevated prostate specific antigen (PSA) levels is considered too costly for widespread National Health Service (NHS) use, as the predictive value of PSA levels for significant disease is poor. Despite the fact that novel blood and urine tests are available which may predict aggressive disease better than PSA, they are not routinely employed due to a lack of clinical validity studies. Furthermore approximately 40 % of mp-MRI studies are reported as indeterminate, which can lead to repeat examinations or unnecessary biopsy with associated patient anxiety, discomfort, risk and additional costs. Methods/Design: We aim to clinically validate a panel of minimally invasive promising blood and urine biomarkers, to better select patients that will benefit from a multiparametric prostate MRI. We will then test whether the performance of the mp-MRI can be improved by the addition of an advanced diffusion-weighted MRI technique, which uses a biophysical model to characterise tissue microstructure called VERDICT; Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours. INNOVATE is a prospective single centre cohort study in 365 patients. mp-MRI will act as the reference standard for the biomarker panel. A clinical outcome based reference standard based on biopsy, mp-MRI and follow-up will be used for VERDICT MRI. Discussion: We expect the combined effect of biomarkers and VERDICT MRI will improve care by better detecting aggressive prostate cancer early and make mp-MRI before biopsy economically viable for universal NHS adoption.
Issue Date: 21-Oct-2016
Date of Acceptance: 12-Oct-2016
URI: http://hdl.handle.net/10044/1/53878
DOI: https://dx.doi.org/10.1186/s12885-016-2856-2
ISSN: 1471-2407
Publisher: BioMed Central
Journal / Book Title: BMC Cancer
Volume: 16
Copyright Statement: © The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: Science & Technology
Life Sciences & Biomedicine
Oncology
BIOPSY
PCA3
MRI
VALIDATION
TISSUE
Algorithms
Biomarkers, Tumor
Biopsy
Clinical Decision-Making
Clinical Protocols
Diffusion Magnetic Resonance Imaging
Humans
Male
Outcome Assessment (Health Care)
Prognosis
Prostatic Neoplasms
Research Design
Workflow
1112 Oncology And Carcinogenesis
Oncology & Carcinogenesis
Publication Status: Published
Article Number: 816
Appears in Collections:Department of Surgery and Cancer