Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004036

Trial Description

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Title

A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher
prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy
in patients with increased PSA values > 4.0 ng/ml.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004036
  •   2012/07/11
  •   2012/03/01
  •   yes
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Secondary IDs

  •   NCT01553838  (ClinicalTrials.gov)
  •   002  (Heinrich-Heine University, Duesseldorf)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Device: MRI guided prostate biopsy and TRUS guided biopsy
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Characteristics

  •   Interventional
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  •   Open (masking not used)
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  •   Diagnostic
  •   Crossover
  •   N/A
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Primary Outcome

- Prostate cancer detection rate; time frame: 3 years

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Secondary Outcome

- Number of Participants with Adverse Events as a measure of Safety and Tolerability; time frame: 3 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/01/31
  •   248
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Inclusion Criteria

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

- PSA > 4.0 ng/ml

- written informed consent

- age >18

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Exclusion Criteria

- patients with prostate cancer

- patients with prior prostate biopsy

- patients with contraindications against MRI or biopsy

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Addresses

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    • Heinrich-Heine University, Duesseldorf
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    • Department of Urology, University of Duesseldorf
    • Christian Arsov, MD 
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    • Department of Urology, University of Duesseldorf
    • Christian Arsov, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2013/10/01
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Trial Publications, Results and other Documents

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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • [---]*
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  • Further contact 
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    • [---]*
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14
* This entry means the parameter is not applicable or has not been set.