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Clinical Trials/NCT01553838
NCT01553838
Completed
N/A

A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values

Heinrich-Heine University, Duesseldorf1 site in 1 country185 target enrollmentJanuary 2012
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
185
Locations
1
Primary Endpoint
Prostate cancer detection rate
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
October 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • PSA \> 4.0 ng/ml
  • written informed consent

Exclusion Criteria

  • patients with prostate cancer
  • patients with prior prostate biopsy
  • patients with contraindications against MRI or biopsy

Outcomes

Primary Outcomes

Prostate cancer detection rate

Time Frame: 3 years

Secondary Outcomes

  • Number of Participants with Adverse Events as a measure of Safety and Tolerability(3 years)

Study Sites (1)

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