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

Open (Enrolling)
Prostate Cancer, Benign Prostatic Hyperplasia, Prostatic Intraepithelial Neoplasia

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Trial Information

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

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?

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

Type of Study:


Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal, Time Perspective: Retrospective/Prospective

Principal Investigator

Martin Schostak, PD Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Charité, Berlin, Germany


Germany: Ethics Commission

Study ID:

EA 4/033/06



Start Date:

September 2005

Completion Date:

September 2006

Related Keywords:

  • Prostate Cancer
  • Benign Prostatic Hyperplasia
  • Prostatic Intraepithelial Neoplasia
  • prostate cancer
  • annexin A3
  • early detection
  • exprimate urine
  • Prostatic Hyperplasia
  • Neoplasms
  • Carcinoma
  • Hyperplasia
  • Prostatic Neoplasms
  • Prostatic Intraepithelial Neoplasia
  • Carcinoma in Situ