Trial document




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  DRKS00019892

Trial Description

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Title

Improvement of detection of clinically significant prostate cancer by combination of molecular urine markers and multiparametric MRI of the prostate

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Prostate cancer is the most common malignant disease of the man. In Germany alone there are approximately 58,000 patients with new diagnosed prostate cancer. Because of demographic development the relative proportion of the elderly population will increase and consecutively the incidence of prostate cancer.
The diagnostic goal is to identify the so called clinically significant prostate cancers, meaning the patients in need of treatment. The current standard for patients with clinical suspicion of prostate cancer includes an MRI of the prostate and a combined targeted and systematic biopsy.
Up to two third of the patients receiving such a biopsy have no or a non clinically significant prostate cancer.
The aim of this study is to reduce the rate of unnecessary MRIs, the rate of unnecessary prostate biopsies and the rate of over diagnoses by using the novel SelectMDx - test. After digital rectal examination the patient collects the first void urine stream which will be assessed for the tumor specific markers DLX1 and HOXC6.
After acquisition of the study population the prospectively collected tests will be assessed and correlated with the results of the prostate biopsy.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The participating centers receive the standardized study protocol to ensure the same implementation at all centers. After patient acquisition the collected patient date is transmitted anonymously to the study leader for the final statistical analysis in cooperation with the biometrical institute of the University of Cologne.

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Organizational Data

  •   DRKS00019892
  •   2019/12/30
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  •   yes
  •   Approved
  •   19-1214, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   SelectMDx - Test
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   IV
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Primary Outcome

A minimum 10% improvement of the diagnostic accuracy of the multi parametric MRI of the prostate

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Secondary Outcome

- Reduction of the rate of unnecessary biopsies
- Reduction of the rate of over-diagnoses
- Development of a predictive nomogram
- Sensitivity, specificity, negative predictive value and positive predictive value of the SelectMDx-Test for patients with negative mpMRI and for PI-RADS 3 lesions
- Type and frequency of adverse events of the mpMRI and the targeted biopsy
- Cost effectiveness analysis with significant cost reduction by avoiding unnecessary mpMRIs and prostate biopsies

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/01/01
  •   640
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Life expectancy > 10 years
- Clinical suspicion of prostate cancer (PSA > 4.0ng/ml and/or positive digitorectal examination)

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Exclusion Criteria

- Prostate cancer in medical history
- Acute prostatitis in the last 6 months
- PSA > 20 ng/ml
- Contraindicaitons for a mpMRI
- PSA affecting interventions (e.g. medication such as 5-alpha reductase inhibitors, azaleas, bicalutamide etc.)

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Addresses

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    • Klinik für Urologie Uniklinik Köln
    • Mr.  Professor Dr. med. Dr. h.c.  Axel  Heidenreich 
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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    • Klinik für Urologie Medizinische Hochschule Hannover
    • Ms.  Privat-Dozentin Dr. med.  Inga  Peters 
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    • Klinik für Urologie Bundeswehrkrankenhaus Koblenz
    • Mr.  Professor Dr. med.  Hans Ulrich  Schmelz 
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    • Klinik für Urologie Medizinische Universität Wien
    • Mr.  Professor Dr. med.  Shahrokh F.  Shariat 
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    • Klinik für Urologie Uniklinik Bonn
    • Mr.  Professor Dr. med.  Manuel  Ritter 
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    • Klinik für Urologie Uniklinik Köln
    • Mr.  Professor Dr. med. Dr. h.c.  Axel  Heidenreich 
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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    • Klinik für Urologie Uniklinik Köln
    • Mr.  Dr. med.  Samy  Mahjoub 
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • MDxHealthNovio Tech Campus
    • Transistorweg 5
    • 6534  Nijmegen
    • Netherlands
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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