Investigation of Three Biomarkers for the Detection of Prostate Cancer
Not yet recruiting
- Conditions
- Cancer of Prostate
- Registration Number
- NCT06554587
- Lead Sponsor
- Medtechtomarket Consulting Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Male patients aged 18 years and over<br><br> - The patient is being investigated for suspected prostate cancer or is on active<br> surveillance<br><br> - The patient is able to give consent to take part in the study<br><br>Exclusion Criteria:<br><br> - A patient who has already taken part in the study<br><br> - A patient with an active urinary tract infection<br><br> - The patient has a prior diagnosis of any other cancer or is receiving any cancer<br> treatment (including ADT)<br><br> - The patient is currently or within the last 4 months enrolled on another study<br> involving an investigational medicinal product
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method An evaluation of the diagnostic performance of the GlycoScore biomarkers for the detection of clinically significant prostate cancer (Gleason score of =7).
- Secondary Outcome Measures
Name Time Method Establishment of a 'GlycoScore' algorithm;An evaluation of the ability of the calculated 'GlycoScore' to distinguish between individual Gleason scores and grade groups;An evaluation of the ability of the calculated 'GlycoScore' to distinguish between CPG groups 1 to 5 (Cambridge Prognostic Group classification);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).