Prostate Cancer Clinical Trial
Official title:
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
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
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?
;
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal
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