Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007601

Trial Description

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Title

A Prospective Randomized Study Comparing the Diagnostic Efficacy of MR-guided in Bore Prostate Biopsy Versus MRI/US Fusion-guided Prostate Biopsy in Men With at Least One Negative Prostate Biopsy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with
additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more
prostate cancers than targeted MR-guided in-bore prostate.

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Brief Summary in Scientific Language

In men with previously negative prostate biopsy and persistent elevated prostate-specific
antigen (PSA) value, it is unclear which strategy offers the highest detection rate for
prostate cancer. The hypothesis of this study is that targeted MRI-guided biopsy combined
with transrectal ultrasound (TRUS)-guided biopsy may potentially detect more cancers than
MRI-guided prostate biopsies alone.

Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA
values will be submitted to a multiparametric MRI examination of the prostate. Subsequently,
all participants will be randomized (1:1) into both study arms. In study arm A patients will
be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted
biopsies will be performed using MRI-guided in-bore prostate biopsy. In study arm B targeted
biopsies will be performed using MRI/TRUS-fusion-guided prostate biopsy with
software-registration (MRI/TRUS image fusion). Patients of study arm B undergo additional
systematic 12-core TRUS-guided prostate biopsy.

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Organizational Data

  •   DRKS00007601
  •   2015/10/28
  •   2014/07/07
  •   yes
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Secondary IDs

  •   NCT02220517  (ClinicalTrials.gov)
  •   003  (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: MR-guided in-bore prostate biopsy
  •   Device: MRI/US fusion-guided prostate biopsy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Parallel
  •   N/A
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Primary Outcome

- Prostate cancer detection rate; time frame: 1 week after biopsy

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/11/30
  •   480
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Inclusion Criteria

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

- At least one prior negative prostate biopsy

- Prostate-specific antigen (PSA) > 4 ng/ml

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Exclusion Criteria

- Known prostate cancer

- Contraindications against MRI

- Contraindications against prostate biopsy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Heinrich-Heine University, Duesseldorf
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    • Department of Urology, University of Düsseldorf
    • Christian Arsov, MD 
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    • Department of Urology, University of Düsseldorf
    • Christian Arsov, MD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/10/01
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Trial Publications, Results and other Documents

  • [---]*
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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 .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.