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
Study Overview
Status
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?
Study Type
Enrollment
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Schostak, PD Dr., University Medical Centre Charité, Berlin, Germany
- Study Director: André Schrattenholz, Prof. Dr., ProteoSys AG, Mainz, Germany
Publications and helpful links
General Publications
- Wozny W, Schroer K, Schwall GP, Poznanovic S, Stegmann W, Dietz K, Rogatsch H, Schaefer G, Huebl H, Klocker H, Schrattenholz A, Cahill MA. Differential radioactive quantification of protein abundance ratios between benign and malignant prostate tissues: cancer association of annexin A3. Proteomics. 2007 Jan;7(2):313-22. doi: 10.1002/pmic.200600646.
- Schostak M, Schwall GP, Poznanovic S, Groebe K, Muller M, Messinger D, Miller K, Krause H, Pelzer A, Horninger W, Klocker H, Hennenlotter J, Feyerabend S, Stenzl A, Schrattenholz A. Annexin A3 in urine: a highly specific noninvasive marker for prostate cancer early detection. J Urol. 2009 Jan;181(1):343-53. doi: 10.1016/j.juro.2008.08.119. Epub 2008 Nov 13.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA 4/033/06
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