Investigation of Three Biomarkers for the Detection of Prostate Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorMedtechtomarket Consulting Ltd

About this trial

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 criteria

Qualifiers

Male patients aged 18 years and over

The patient is being investigated for suspected prostate cancer or is on active surveillance

The patient is able to give consent to take part in the study

Disqualifiers

A patient who has already taken part in the study

A patient with an active urinary tract infection

The patient has a prior diagnosis of any other cancer or is receiving any cancer treatment (including ADT)

The patient is currently or within the last 4 months enrolled on another study involving an investigational medicinal product

Trial design

Treatments tested in this trial

  • Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)

Treatment groups

137 Participants
are divided into 1 treatment group

Sponsors and collaborators

Medtechtomarket Consulting Ltd

Lead sponsor

GlycoscoreDx Ltd

Collaborator