Back to resultsA Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MRI guided prostate biopsy and TRUS guided biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate biopsy, MRI guided biopsy, TRUS guided biopsy
Eligibility Criteria
Inclusion Criteria:
- PSA > 4.0 ng/ml
- written informed consent
- age >18
Exclusion Criteria:
- patients with prostate cancer
- patients with prior prostate biopsy
- patients with contraindications against MRI or biopsy
Sites / Locations
- Department of Urology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sequentially MRI guided and TRUS guided biopsy
Arm Description
Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy
Outcomes
Primary Outcome Measures
Prostate cancer detection rate
Secondary Outcome Measures
Number of Participants with Adverse Events as a measure of Safety and Tolerability
Full Information
NCT ID
NCT01553838
First Posted
March 1, 2012
Last Updated
August 18, 2014
Sponsor
Heinrich-Heine University, Duesseldorf
1. Study Identification
Unique Protocol Identification Number
NCT01553838
Brief Title
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
Official Title
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values > 4.0 ng/ml.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate biopsy, MRI guided biopsy, TRUS guided biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequentially MRI guided and TRUS guided biopsy
Arm Type
Experimental
Arm Description
Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy
Intervention Type
Device
Intervention Name(s)
MRI guided prostate biopsy and TRUS guided biopsy
Intervention Description
MRI guided prostate biopsy
Primary Outcome Measure Information:
Title
Prostate cancer detection rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a measure of Safety and Tolerability
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
PSA > 4.0 ng/ml
written informed consent
age >18
Exclusion Criteria:
patients with prostate cancer
patients with prior prostate biopsy
patients with contraindications against MRI or biopsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Arsov, MD
Organizational Affiliation
Department of Urology, University of Duesseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
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