Table 5.

Primary and secondary outcome measures

Primary outcome

Radiological assessment with added VERDICT MRI improves the diagnostic accuracy of mp-MRI for detection of significant prostate cancer by a minimum of 10 %

Secondary outcomes

• A group of diagnostic fluidic markers measured on the MesoScale discovery (MSD) platform and/or in DNA and RNA, can predict patients with a negative mp-MRI result (i.e. 1-2/5 Likert score).

• The use of patient serum-derived exosomes as ‘liquid biopsies’ for the identification of genomic and molecular aberrations that can be used to better predict patients with aggressive or high volume prostate cancer

• Technical validation of VERDICT:

○ VERDICT MRI is qualitatively and quantitatively repeatable

• Biological validation of VERDICT:

○ VERDICT cellularity measure correlates with histological cell density

○ VERDICT intracellular volume fraction correlates with segmented fractional histological intracellular component

○ VERDICT vascular volume fraction correlates with segmented fractional histological vascular component

○ VERDICT extracellular extravascular volume fraction correlates with fractional segmented histological glandular component + stromal component

• Set-up of imaging/fluidic marker outcome linked database