NCT00400894

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
Last Updated

February 5, 2007

Status Verified

February 1, 2007

First QC Date

November 16, 2006

Last Update Submit

February 2, 2007

Conditions

Keywords

prostate cancerannexin A3early detectionexprimate urine

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a histological confirmation of adenocarcinoma of the prostate
  • Patients with benign prostatic hyperplasia (confirmed by histology of lance biopsies or TUR-P)

You may not qualify if:

  • Patients with rectal extirpation
  • Patients with renal or bladder tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 17205602BACKGROUND
  • 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.

MeSH Terms

Conditions

Prostatic NeoplasmsProstatic HyperplasiaProstatic Intraepithelial Neoplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Martin Schostak, PD Dr.

    University Medical Centre Charité, Berlin, Germany

    PRINCIPAL INVESTIGATOR
  • André Schrattenholz, Prof. Dr.

    ProteoSys AG, Mainz, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

September 1, 2005

Study Completion

September 1, 2006

Last Updated

February 5, 2007

Record last verified: 2007-02