NCT00400894

Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 750 (planned)
• Sponsor: ProteoSys AG · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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 description

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?

Conditions

• Prostate Cancer
• Benign Prostatic Hyperplasia
• Prostatic Intraepithelial Neoplasia

Timeline

• Start date: 2005-09-01
• Completion: 2006-09-01
• First posted: 2006-11-17
• Last updated: 2007-02-05