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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: MRI guided prostate biopsy and TRUS guided biopsy

• Registration Number: NCT01553838
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-14
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequentially MRI guided and TRUS guided biopsy	MRI guided prostate biopsy and TRUS guided biopsy	Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy

Primary Outcome Measures

Name	Time	Method
Prostate cancer detection rate	3 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a measure of Safety and Tolerability	3 years

Trial Locations

Locations (1)

Department of Urology; 🇩🇪 Duesseldorf, Germany