EV Biomarkers for PCa_Version 1
Research type
Research Study
Full title
Utilising extracellular vesicles for early detection of clinically significant prostate cancer
IRAS ID
305711
Contact name
Jason P Webber
Contact email
Sponsor organisation
Swansea University
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Men in UK have 1 in 6 chance of being diagnosed with Prostate cancer (PCa). Nearly one third of new prostate cancer diagnosis have lowest grade cancer which is considered to be insignificant cancers. A lack in sensitivity and specificity of current diagnostic tests (e.g. PSA blood test) results in unnecessary treatment to men who do not need it. Some of these cancers will, however, progress and there is currently an under diagnosis of men who are at risk of clinically significant disease when not treated. This causes great deal of stress and anxiety to patients. We need an effective tool that is simple, scalable and reliable to use test, that can be effectively used to differentiate between clinically insignificant and significant cancers.
The study aim is to develop potential biomarkers for early identification of patients with clinically significant PCa. There is much interest in the use of extracellular vesicles (EVs) as cancer biomarkers, and elevated levels of EVs reported in serum and urine from PCa patients. We have previously identified several biomarkers within EVs (including proteins and RNA) that can help to distinguish patients with clinically significant disease from those with insignificant disease.
This study will assess EV-associated biomarkers by evaluating their expression levels in patient blood (serum and plasma) and urine. We will test identified biomarkers on broad sample cohorts for evaluation of the feasibility of our assay for clinical use. We will therefore determine EV biomarker correlation with additional clinical features including, but not limited to, multi-parametric magnetic resonance imaging (mp-MRI), Gleason Score, TNM stage and PSA as recorded in the clinical data. We will also validate identified biomarker candidates using archived FFPE prostate tissue specimens collected, either from surgery or during routine biopsy, as part of the standard care received by patients undergoing diagnostic testing for prostate cancer.
REC name
Wales REC 5
REC reference
23/WA/0087
Date of REC Opinion
23 Mar 2023
REC opinion
Favourable Opinion