Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008804

Trial Description

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Title

Prospective Multicenter, Randomized Study Comparing the Diagnostic Efficacy of a Targeted MRI/Ultrasound Fusion-guided Prostate Biopsy Versus a Systematic Transrectal Ultrasound-guided Biopsy in Men With at Least on Negative Prostate Biopsy

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Trial Acronym

PROFUSE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients 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 the gold-standard which comprises systematic transrectal
ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted
prostate biopsy based on the multiparametric MRI findings.

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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 biopsy strategy offers the highest detection rate
for significant prostate cancer. The hypothesis of this study is that targeted
MRI/ultrasound fusion-guided biopsy improves the detection rates of significant prostate
cancers compared with systematic transrectal ultrasound-guided prostate biopsy.

Men with at least one previously negative transrectal ultrasound-guided biopsy and
persistently elevated PSA values (> 3 ng/ml) or PSA velocity >0.75 ng/ml/p.a. 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 the gold-standard which comprises systematic transrectal ultrasound--guided
prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based
on the multiparametric MRI findings. Targeted biopsies will be performed using
MRI/ultrasound fusion-guided.

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Organizational Data

  •   DRKS00008804
  •   2015/06/23
  •   2015/05/19
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT02450266  (ClinicalTrials.gov)
  •   004  (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: Systematic transrectal ultrasound-guided prostate biopsy
  •   Device: MRI/ultrasound fusion-guided prostate biopsy
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Characteristics

  •   Interventional
  •   [---]*
  •   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

- Detection rate of significant prostate cancers; time frame: One week after biopsy

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Secondary Outcome

- Overall detection rate of prostate cancers; time frame: One week after biopsy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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  •  
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Recruitment

  •   [---]*
  •   2015/02/27
  •   586
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- At least one negative transrectal ultrasound-guided prostate biopsy

- PSA > 3.0 ng/ml or PSA velocity >0.75 ng/ml/p.a.

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Exclusion Criteria

- Known prostate cancer

- PSA >50 ng/ml

- Previous MRI-targeted prostate biopsy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Heinrich-Heine University, Duesseldorf
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    • German Cancer Research Center
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    •   [---]*
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    • Department of Urology, University Hospital Düsseldorf
    • Christian Arsov, MD 
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    • 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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    •   [---]*
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Status

  •   Recruiting ongoing
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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 .
  •   2
  •   2016/01/14


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