Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy
NCT ID: NCT02450266
Last Updated: 2015-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
586 participants
INTERVENTIONAL
2015-02-28
2018-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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A: Transrectal ultrasound-guided biopsy
Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)
Systematic transrectal ultrasound-guided prostate biopsy
12-18 systematic biopsy cores
B: MRI/ultrasound fusion-guided biopsy
Patients of arm B receive a targeted MRI/ultrasound fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
MRI/ultrasound fusion-guided prostate biopsy
2 targeted biopsy cores from each prostate lesion
Interventions
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Systematic transrectal ultrasound-guided prostate biopsy
12-18 systematic biopsy cores
MRI/ultrasound fusion-guided prostate biopsy
2 targeted biopsy cores from each prostate lesion
Eligibility Criteria
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Inclusion Criteria
* PSA \> 3.0 ng/ml or PSA velocity \>0.75 ng/ml/p.a.
Exclusion Criteria
* PSA \>50 ng/ml
* Previous MRI-targeted prostate biopsy
18 Years
MALE
Yes
Sponsors
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German Cancer Research Center
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Principal Investigators
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Christian Arsov, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, University Hospital Düsseldorf
Locations
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Department of Urology, Charité-Universitätsmedizin
Berlin, , Germany
Department of Urology, University Hospital Düsseldorf
Düsseldorf, , Germany
Department of Urology, University Hospital Jena
Jena, , Germany
Countries
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Central Contacts
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Facility Contacts
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Kurt Miller, MD
Role: primary
Marc O Grimm, MD
Role: primary
Other Identifiers
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004
Identifier Type: -
Identifier Source: org_study_id
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