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

This study is ongoing, but not recruiting participants.

First Received: November 16, 2006 Last Updated: February 2, 2007 History of Changes

Sponsor:	ProteoSys AG
Collaborators:	Charite University, Berlin, Germany University Hospital Tuebingen Medical Centre, Ludwigshafen, Germany Medical University Innsbruck
Information provided by:	ProteoSys AG
ClinicalTrials.gov Identifier:	NCT00400894

Purpose

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

Condition
Prostate Cancer Benign Prostatic Hyperplasia Prostatic Intraepithelial Neoplasia

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title:	Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Urine and Urination

U.S. FDA Resources

Further study details as provided by ProteoSys AG:

Estimated Enrollment:	750
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2006

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?

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400894

Sponsors and Collaborators

ProteoSys AG

Charite University, Berlin, Germany

University Hospital Tuebingen

Medical Centre, Ludwigshafen, Germany

Medical University Innsbruck

Investigators

Principal Investigator:	Martin Schostak, PD Dr.	University Medical Centre Charité, Berlin, Germany
Study Director:	André Schrattenholz, Prof. Dr.	ProteoSys AG, Mainz, Germany

More Information

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Schostak M, Schwall GP, Poznanović S, Groebe K, Müller 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. Epub 2008 Nov 13.

Study ID Numbers:	EA 4/033/06
Study First Received:	November 16, 2006
Last Updated:	February 2, 2007
ClinicalTrials.gov Identifier:	NCT00400894 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by ProteoSys AG:

prostate cancer
annexin A3
early detection
exprimate urine

Additional relevant MeSH terms:

Prostatic Intraepithelial Neoplasia
Neoplasms by Histologic Type
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Carcinoma
Hyperplasia

Neoplasms
Pathologic Processes
Neoplasms by Site
Prostatic Hyperplasia
Carcinoma in Situ
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009