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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00400894
• Other study ID #: EA 4/033/06
• Status: Active, not recruiting
• Phase: N/A
• First received: November 16, 2006
• Last updated: February 2, 2007
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: February 2007
• Source: ProteoSys AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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

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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Carcinoma in Situ
• Hyperplasia
• Prostate Cancer
• Prostatic Hyperplasia
• Prostatic Intraepithelial Neoplasia
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
ProteoSys AG	Charite University, Berlin, Germany, Medical Centre, Ludwigshafen, Germany, Medical University Innsbruck, University Hospital Tuebingen

References & Publications (1)

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. — View Citation