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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553838
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: August 18, 2014
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2012
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• MRI guided prostate biopsy and TRUS guided biopsy
MRI guided prostate biopsy

Locations

Country	Name	City	State
Germany	Department of Urology	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer detection rate		3 years	Yes
Secondary	Number of Participants with Adverse Events as a measure of Safety and Tolerability		3 years	Yes