A multi-site study to evaluate the potential use of the ChEC test of seminal fluid as an additional triage test in stratifying patients for further tests.
A biomarker is a molecular substance that is an indicator of a biological condition. Cambridge Oncometrix believe that a semen biomarker may be able to predict the presence of prostate cancer. This study will allow work to be carried out on semen samples donated by men who have been identified by their GPs as having a risk of prostate cancer. Normally, GPs refer men with symptoms or a raised PSA to hospital to have an MRI scan and a biopsy. The PLiS research team at the hospital will contact potential patients, who have been referred by their GPs, before they have an MRI or a biopsy, ask them if they are willing to take part in the study, consent them and ask them to provide a semen sample. Semen samples will be produced by the potential participants at home into a seminal fluid collection container, they will also have to complete a study questionnaire. Both the sample and the questionnaire will be returned to the central laboratory in Cambridge using the stamped addressed envelope provided. In addition to providing a semen sample and completing a questionnaire, each participant will have two blood tests to measure male hormones. Participants then exit the trial and their usual care carries on from this point. The PLiS study will register 400 men and of those it is hoped that 300 of them will be able to provide semen.
Study Type
OBSERVATIONAL
Enrollment
300
Patients will be asked to donate a semen sample which will be analysed and compared with their eventual diagnosis.
University College Hospital
London, United Kingdom
RECRUITINGNorfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
RECRUITINGMetrics of the ChEC-S test
Sensitivity, specificity, negative and positive predictive values, and reciever operating characteristics (area under the curve) in the participants with a high risk of prostate cancer using mpMRI as a clinical reference standard.
Time frame: 18 Months
Threshold
Optimal threshold for the ChEC-S diagnostic score
Time frame: 18 Months
Proportion
Proportion of men who could safely avoid an MRI targeted biopsy as determined by specificity and negative predictive values of the ChEC-S test at the optimal ChEC-S test cut-off levels
Time frame: 18 Months
Proportion of significance
Proportion of men correctly identified of ChEC-S test to have clinically significant prostate cancer
Time frame: 18 Months
Value
Value of the ChEC-S test as a prognostic marker of clinically significant prostate cancer (a positive predictive value). Evaluation of the prognostic power of the chemical elements as biomarkers of aggressive prostate cancer using Gleason score as clinical reference standard.
Time frame: 18 Months
Hypogonadism Impact
The impact of hypogonadism on the ChEC-S score
Time frame: 18 Months
Resource
Resource use and costs for further economic evaluation
Time frame: 18 Months
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