RecruitingNCT06554587

Investigation of Three Biomarkers for the Detection of Prostate Cancer

Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer

Sponsor

Medtechtomarket Consulting Ltd

Enrollment

137 participants

Start Date

Jan 7, 2025

Study Type

OBSERVATIONAL

Conditions

Cancer of Prostate

Summary

GlycoScore Dx Limited, a diagnostics company based in the United Kingdom have identified three glycoproteins, that showed promise as biomarkers of prostate cancer in initial validation studies. The purpose of this study is to further evaluate the sensitivity and specificity of the GlycoScore biomarkers for the detection of clinically significant prostate cancer. Sensitivity and specificity will be determined for each marker, combinations of the three markers and combinations of the GlycoScore biomarkers with PSA (prostate specific antigen). The results from this study will be used to identify the most suitable biomarker/biomarkers for use in developing a GlycoScore test. This is a prospective, non-interventional study using venous blood samples taken from patients with suspected prostate cancer or on active surveillance, attending the hospital Urology department for a transperineal biopsy.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating three blood or urine biomarkers to see if they can improve the detection of prostate cancer. Prostate cancer is often detected with the PSA blood test, but PSA alone can miss cancers or cause unnecessary biopsies. Better markers could help doctors decide who really needs a biopsy. **You may be eligible if...** - You are a man aged 18 or older - You are currently being investigated for suspected prostate cancer (e.g., elevated PSA, abnormal exam) or are on active surveillance for known prostate cancer - You are able to give consent to participate **You may NOT be eligible if...** - You have already taken part in this same study - You have an active urinary tract infection - You have a prior diagnosis of any other cancer or are on any cancer treatment (including hormone therapy for prostate cancer) - You have been in another drug trial within the last 4 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTLaboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)

Measurement of the plasma concentration of ST6GAL1, GCNT1 and GALNT7 biomarkers in patients suspected of having prostate cancer or on active surveillance