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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-09-30

Brief Summary

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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

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Detailed Description

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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

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Prostate Cancer Benign Prostatic Hyperplasia Prostatic Intraepithelial Neoplasia

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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)