This trial is active, not recruiting.

Conditions prostate cancer, benign prostatic hyperplasia, prostatic intraepithelial neoplasia
Sponsor ProteoSys AG
Collaborator Charite University, Berlin, Germany
Start date September 2005
End date September 2006
Trial size 750 participants
Trial identifier NCT00400894, EA 4/033/06


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model defined population
Primary purpose screening
Time perspective longitudinal

Eligibility Criteria

Male participants of any age.

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

Additional Information

Official title Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
Principal investigator Martin Schostak, PD Dr.
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?
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by ProteoSys AG.