Clinical trial NCT00400894: Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
Official title: Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Benign Prostatic Hyperplasia
Prostatic Intraepithelial Neoplasia
Keywords: prostate cancer
annexin A3
early detection
exprimate urine
Lead sponsor: ProteoSys AG
Sponsor class: INDUSTRY
Collaborators: name: Charite University, Berlin, Germany
name: University Hospital Tuebingen
name: Medical Centre, Ludwigshafen, Germany
name: Medical University Innsbruck
First posted: 2006-11-17
Enrollment: 750
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: 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

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Centre Charité, Berlin, Germany
name: Martin Schostak, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: ProteoSys AG, Mainz, Germany
name: André Schrattenholz, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.