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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01553838

Enrollment

185

Registered

2012-03-14

Start date

2012-01-31

Completion date

2013-10-31

Last updated

2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate biopsy, MRI guided biopsy, TRUS guided biopsy

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.

Interventions

DEVICEMRI guided prostate biopsy and TRUS guided biopsy

MRI guided prostate biopsy

Study design

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Prostate cancer detection rate	3 years

Secondary

Measure	Time frame
Number of Participants with Adverse Events as a measure of Safety and Tolerability	3 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026