Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy
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
1 other identifier
interventional
480
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMarch 24, 2015
March 1, 2015
2.8 years
July 7, 2014
March 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prostate cancer detection rate
1 week after biopsy
Study Arms (2)
A: MR-guided in-bore prostate biopsy
EXPERIMENTALPatients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
B: MRI/US fusion-guided prostate biopsy
EXPERIMENTALPatients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)
Interventions
Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)
Eligibility Criteria
You may qualify if:
- At least one prior negative prostate biopsy
- Prostate-specific antigen (PSA) \> 4 ng/ml
You may not qualify if:
- Known prostate cancer
- Contraindications against MRI
- Contraindications against prostate biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Düsseldorf
Düsseldorf, 40225, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Arsov, MD
Department of Urology, University of Düsseldorf
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2014
First Posted
August 20, 2014
Study Start
November 1, 2011
Primary Completion
August 1, 2014
Study Completion
October 1, 2014
Last Updated
March 24, 2015
Record last verified: 2015-03