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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by ProteoSys AG.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Charite University, Berlin, Germany
University Hospital Tuebingen
Medical Centre, Ludwigshafen, Germany
Medical University Innsbruck
Information provided by:
ProteoSys AG
ClinicalTrials.gov Identifier:
NCT00400894
First received: November 16, 2006
Last updated: February 2, 2007
Last verified: February 2007
  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: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma

Resource links provided by NLM:


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
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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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00400894     History of Changes
Other Study ID Numbers: EA 4/033/06
Study First Received: November 16, 2006
Last Updated: February 2, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by ProteoSys AG:
prostate cancer
annexin A3
early detection
exprimate urine

Additional relevant MeSH terms:
Prostatic Hyperplasia
Neoplasms
Carcinoma
Hyperplasia
Prostatic Neoplasms
Prostatic Intraepithelial Neoplasia
Carcinoma in Situ
Prostatic Diseases
Genital Diseases, Male
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 23, 2014