Investigation of Three Biomarkers for the Detection of Prostate Cancer
ConditionCancer of Prostate
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
This trial does not accept healthy volunteersQualifiers
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 population
Male patients referred to the secondary care (urology clinic) for transperineal biopsy for the investigation of suspected prostate cancer or patients undergoing active surveillance
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)
Diagnostic testMeasurement of the plasma concentration of ST6GAL1, GCNT1 and GALNT7 biomarkers in patients suspected of having prostate cancer or on active surveillance
Treatment groups
137 Participants
are divided into 1 treatment groupGroup A: Patients with suspected prostate cancer or on active surveillance1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-biopsy (one time point)Secondary outcomes
1
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).
Time frame
Pre-biopsy (one time point)2
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
Time frame
Pre-biopsy (one time point)3
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
Time frame
Pre-biopsy (one time point)4
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
Time frame
Pre-biopsy (one time point)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medtechtomarket Consulting Ltd
Lead sponsor
GlycoscoreDx Ltd
Collaborator
Source ClinicalTrials.gov