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.