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

BMC Cancer

Study Protocol

Daniel Alexander¹  Eleftheria Panagiotaki¹  Elisenda Bonet-Carne¹  David Hawkes¹  Giorgia Trevisan²  Dominic Patel²  Alexander Freeman²  Manuel Rodriguez-Justo²  Hashim U Ahmed³  Mark Emberton³  Caroline Moore³  Tony Ng⁴  Myria Galazi⁴  Hayley Pye⁵  Keith Burling⁵  Hayley Whitaker⁵  Susan Heavey⁵  Lina Carmona⁵  Clare Allen⁶  Edward Johnston⁶  David Atkinson⁶  Alexander Kirkham⁶  Shonit Punwani⁶  Nicola Stevens⁶ 

[1] Department of Computer Science, UCL, Gower Street, WC1E 6BT, London, UK;Department of Research Pathology, UCL Cancer Institute, Rockefeller Building, 21 University Street, WC1E 6JJ, London, UK;Division of Surgery, 4th floor, 21 University Street, WC1E, London, UK;Molecular Oncology group, UCL Cancer Institute, Paul O’Gorman Building, 72 Huntley Street, WC1E 6DD, London, UK;Research Department for Tissue & Energy, Division of Surgery & Interventional Science, Wing 2.4 Cruciform Building, Gower Street, WC1E 6BT, London, UK;Addenbrookes Hospital, Level 4, Pathology Block, Hills Road, CB20QQ, Cambridge, UK;UCL Centre for Medical Imaging, 5th floor, Wolfson House, 4 Stephenson Way, NW1 2HE, London, UK;

关键词: Prostate Cancer;    Apparent Diffusion Coefficient;    Prostate Specific Antigen;    Prostate Specific Antigen Level;    Prostate Cancer Antigen;   

DOI  :  10.1186/s12885-016-2856-2

 received in 2016-04-20, accepted in 2016-10-12,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundWhilst 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/DesignWe 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.DiscussionWe 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.Trial registrationINNOVATE is registered on ClinicalTrials.gov, with reference NCT02689271.

【 授权许可】

CC BY   
© The Author(s). 2016