Pre-biopsy prostate biomarker study
Research type
Research Study
Full title
A prospective pre-biopsy study of non-invasive prostate cancer biomarkers in the urine, blood and prostates of men at risk of prostate cancer.
IRAS ID
197708
Contact name
Alan McNeill
Contact email
Sponsor organisation
NHS Lothian
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The project will evaluate a novel elasticity assessment tool (E-finger) along with urine (MCM-2) and blood (ctDNA) markers for the detection of prostate cancer in 500 patients, with the specific aim of distinguishing clinically significant (aggressive) disease from non-aggressive disease at the pre-biopsy stage. If successful, these markers could in the future replace conventional finger examination of the prostate and will form the basis of a predictive model to better select patients for prostate biopsy. As data on outcomes become available, using these markers regularly within a unit will also enable better classification and stratification of risk of disease by incorporating mechanical markers into existing staging models.
The study design is a prospective comparison study between current gold standard testing (PSA & DRE-finger examination of prostate and Transrectal ultrasound guided prostate biopsy) with these less invasive markers. The study will involve patients giving written informed consent then giving a urine sample (which is standard before a biopsy - the excess unused urine will be taken and used in the research), it will involve having a blood test done (which is standard before a biopsy to repeat a PSA - the excess blood unused will be taken and used in the research) and to have an E-finger assessment. This will involve the patient having an assessment of the prostate using the E-finger probe. This is much like having a finger examination of the prostate and will last approximately 5 minutes.
The research is being funded by The Urology Foundation (TUF). Participants will be recruited from the TRUS prostate biopsy service - this service is for men at risk of having prostate cancer. Patients will have information regarding the study posted to them along with their appointment cards and then will be approached before their biopsy to ascertain if they would be interested in taking part (research nurse).REC name
South East Scotland REC 02
REC reference
16/SS/0133
Date of REC Opinion
18 Aug 2016
REC opinion
Further Information Favourable Opinion