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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00400894
Enrollment
750
Registered
2006-11-17
Start date
2005-09-30
Completion date
2006-09-30
Last updated
2007-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Prostate Cancer, Prostatic Intraepithelial Neoplasia

Keywords

prostate cancer, annexin A3, early detection, exprimate urine

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?

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
Medical Centre, Ludwigshafen, Germany
CollaboratorUNKNOWN
Medical University Innsbruck
CollaboratorOTHER
ProteoSys AG
Lead SponsorINDUSTRY

Study design

Observational model
DEFINED_POPULATION
Time perspective
OTHER

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026