INNOVATE: A prospective cohort study combining serum and urinary biomarkers with novel diffusion-weighted MR imaging for the prediction and characterisation of prostate cancer.


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Hayley Whitaker1,Hayley Pye2,Lina Carmona2,Susan Heavey2,Alex Freeman2,Manuel Rodriguez-Justo2,Daniel Alexander2,Eleftheria Panagiotaki2,Edward Johnston3,Teresita Beeston3,Hashim Ahmed2,Tony Ng4,Shonit Punwani3
1University College London,2UCL,3UCLH,4CRUK

Abstract

Background

Whilst multi-parametric MRI (mp-MRI) has been a significant advance in prostate cancer management, scanning all patients with elevated prostate specific antigen (PSA) levels is considered too costly for widespread NHS use, as the predictive value of PSA levels for significant prostate cancer 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, if patients do undergo mp-MRI, approximately 40% of studies will be indeterminate, which can lead to repeat examinations or unnecessary biopsy with associated patient discomfort, risk and additional costs.

Method

In this study, we will address these two interlinked problems. Firstly, we aim to clinically validate a panel of promising blood and urine biomarkers, to better select patients that will benefit from a multiparametric prostate MRI. Secondly, we will test whether the performance of the mp-MRI can be improved by the addition of an advanced diffusion-weighted MRI technique called VERDICT, which uses a biophysical model to characterise tissue microstructure. 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.

Conclusion

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.