Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy
PROFUSE
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
1 other identifier
interventional
586
1 country
3
Brief Summary
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.
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 Feb 2015
3 active sites
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
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMay 21, 2015
May 1, 2015
2 years
May 19, 2015
May 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection rate of significant prostate cancers
One week after biopsy
Secondary Outcomes (1)
Overall detection rate of prostate cancers
One week after biopsy
Study Arms (2)
A: Transrectal ultrasound-guided biopsy
ACTIVE COMPARATORPatients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)
B: MRI/ultrasound fusion-guided biopsy
EXPERIMENTALPatients 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.
Interventions
12-18 systematic biopsy cores
2 targeted biopsy cores from each prostate lesion
Eligibility Criteria
You may qualify if:
- At least one negative transrectal ultrasound-guided prostate biopsy
- PSA \> 3.0 ng/ml or PSA velocity \>0.75 ng/ml/p.a.
You may not qualify if:
- Known prostate cancer
- PSA \>50 ng/ml
- Previous MRI-targeted prostate biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Urology, Charité-Universitätsmedizin
Berlin, 12200, Germany
Department of Urology, University Hospital Düsseldorf
Düsseldorf, 40225, Germany
Department of Urology, University Hospital Jena
Jena, 07743, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Arsov, MD
Department of Urology, University Hospital Düsseldorf
Central Study Contacts
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
May 19, 2015
First Posted
May 21, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2017
Study Completion
February 1, 2018
Last Updated
May 21, 2015
Record last verified: 2015-05