Clinical Trial: Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
Brief Summary:
Emerging from a differential proteomic study of sample pairs of prostate cancer and benign tissue, annexin A3 (ANXA3) was chosen as a potential novel biomarker for the early and non-invasive diagnosis of prostate cancer. We wanted to show or investigate, that:
- ANXA3 can be detected in urine after standard digital rectal examination.
- ANXA3 has better specificities than tPSA, in particular in the grey zone of PSA
- ANXA3 can help avoid unnecessary biopsies
- ANXA3 can in the long run replace PSA as a marker
Detailed Summary:
The aim of this multi centre and double-blinded study was to investigate specificities and sensitivities of early detection of prostate cancer with a new protein biomarker, annexin A3, using urine after digital rectal examination/massage (exprimate urine) in direct comparison to the corresponding measurements of the gold standard, total PSA. The material obtained by this non-invasive procedure was moreover used to determine appropriate cut-off values and optimal fractions (e.g. after centrifugation) and calibrations for quantitative measurements of this novel marker.
Patients (500-750) were (and are) continuously recruited from four clinical centres in Germany (Berlin, Tübingen, Ludwigshafen) and Austria (Innsbruck). The major aspect was:
• Can annexin A3 provide a better specificity than tPSA, in particular in the grey zone of PSA (2-10 ng/ml) and can annexin A3 thus contribute to a significant reduction of invasive transrectal biopsies?
Sponsor: ProteoSys AG
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: ProteoSys AG
Dates:
Date Received: November 16, 2006
Date Started: September 2005
Date Completion: September 2006
Last Updated: February 2, 2007
Last Verified: February 2007