Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
This trial is active, not recruiting.
|Conditions||prostate cancer, benign prostatic hyperplasia, prostatic intraepithelial neoplasia|
|Collaborator||Charite University, Berlin, Germany|
|Start date||September 2005|
|End date||September 2006|
|Trial size||750 participants|
|Trial identifier||NCT00400894, EA 4/033/06|
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
|Observational model||defined population|
Male participants of any age.
Inclusion Criteria: - Patients with a histological confirmation of adenocarcinoma of the prostate - Patients with benign prostatic hyperplasia (confirmed by histology of lance biopsies or TUR-P) Exclusion Criteria: - Patients with rectal extirpation - Patients with renal or bladder tumors
|Official title||Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma|
|Principal investigator||Martin Schostak, PD Dr.|
|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?|
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