Trial document




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  DRKS00003155

Trial Description

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Title

The relevance of serum microRNAs in the diagnosis of prostate cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Prostate cancer is the most common malignancy in men. Prostate specific antigen (PSA) screening is often performed, although the diagnostic accuracy, especially in the "grey-zone" (4-10ng/ml), is limited. Additional tumor markers are warranted to optimize the diagnosis of prostate cancer. The present study is designed to investigate the diagnostic value of cell-free circulating microRNA in patients undergoing prostate biopsy. We hypothesize that serum mir-26a has a superior diagnostic accuracy than PSA testing, and could serve as adjunct biomarker in the diagnosis of prostate cancer.

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Brief Summary in Scientific Language

MicroRNAs are short RNA, which influence as oncogene or tumorsuppressor gene growth, differentiation and proliferation. It was shown that microRNA profiles are different in neoplastic and non-neoplastic cells of a single organ, but also allow to differentiate between various tumor entities. MicroRNAs are circulating in blood, and are resistant against degradation by RNases; thus, they represent a potential tumor marker.
Prostate cancer patients have increased levels of circulating micorRNAs; miR-26a allowed to distinguish accurately between patients with prostate cancer and benign prostate hyperplasia in a pilot study. Thus, serum samples from a large cohort of patients undergoing prostate biopsy should be collected, and the amount of circulating miR-26a quantified using real-time PCR. The diagnostic accuracy of miR-26a should be compared to PSA and %fPSA.

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Organizational Data

  •   DRKS00003155
  •   2011/06/22
  •   [---]*
  •   yes
  •   Approved
  •   141/11, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   a serum sample will be collected from all patients prior prostate biopsy to analyse circulating miR-26a and PSA / %fPSA
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Analysis and comparison of the diagnostic accuracy of miR-26a, PSA and %fPSA

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Secondary Outcome

Difference of microRNA levels in differnet tumor stages

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/07/04
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   40   Years
  •   no maximum age
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Additional Inclusion Criteria

- indication of prostate biopsy according the S3-guideline prostate cancer, suspicion of prostate cancer (e.g. PSA elevation, abnormal digital-rectal examination, abnormal transrectal sonography)
- age > 40 years
- sex: male

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Exclusion Criteria

history of secondary malignancy within the last 5 years

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Addresses

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    • Universitätsklinikum Bonn Klinik und Poliklinik für Urologie und Kinderurologie
    • Mr.  Dr. med.  Jörg  Ellinger 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Münster Urologie
    • Mr.  Rudolf  Moritz 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinikum Bonn Klinik und Poliklinik für Urologie und Kinderurologie
    • Mr.  Dr. med.  Jörg  Ellinger 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn Klinik und Poliklinik für Urologie und Kinderurologie
    • Mr.  Dr. med.  Jörg  Ellinger 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Bonn Klinik und Poliklinik für Urologie und Kinderurologie
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2013/02/27
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Trial Publications, Results and other Documents

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