Investigation of Three Biomarkers for the Detection of Prostate Cancer
NCT Number: NCT06554587
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer of Prostate
Interventions: DIAGNOSTIC_TEST: Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)
Sponsor: Medtechtomarket Consulting Ltd
Collaborators: GlycoscoreDx Ltd
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 137
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-10

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.

Primary Outcome Measures: An evaluation of the diagnostic performance of the GlycoScore biomarkers for the detection of clinically significant prostate cancer (Gleason score of ≥7)., A comparison of calculated sensitivity, specificity and positive and negative predictive values for clinically significant prostate cancer for the following:

Each biomarker, alone and in combination with PSA (measured on from the same blood sample using a CE-marked assay)

Each possible combination of GlycoScore biomarkers, alone and in combination with PSA

The reference method for diagnosis of prostate cancer will be biopsy, and the reference method for identifying patients who do not have cancer will be by a combination of mpMRI and/or biopsy., Pre-biopsy (one time point)
Secondary Outcome Measures: Establishment of a 'GlycoScore' algorithm, Establish an algorithm for calculating a 'GlycoScore' that converts the assay results from the optimal combination of biomarkers into a score that indicates the likelihood that a patient has clinically significant prostate cancer (Gleason score of ≥7)., Pre-biopsy (one time point)|An evaluation of the ability of the calculated 'GlycoScore' to distinguish between individual Gleason scores and grade groups, Correlation between the calculated 'GlycoScore' from each sample and Gleason score and grade groups at biopsy, Pre-biopsy (one time point)|An evaluation of the ability of the calculated 'GlycoScore' to distinguish between CPG groups 1 to 5 (Cambridge Prognostic Group classification), Correlation between the calculated 'GlycoScore' from each sample and the Cambridge Prognostic Group classification, Pre-biopsy (one time point)|A comparison of the diagnostic performance of the GlycoScore biomarkers (with and without PSA) against the performance of the hospital PSA test alone for the detection of clinically significant prostate cancer (Gleason score of ≥7)., A comparison of calculated sensitivity, specificity and positive and negative predictive values for clinically significant prostate cancer, Pre-biopsy (one time point)