Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
Recruitment status was Active, not recruiting
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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 Time Perspective: Retrospective/Prospective |
| Official Title: | Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma |
| Estimated Enrollment: | 750 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2006 |
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 |
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| 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 June 18, 2013