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, Duesseldorf185 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

185

Conditions

Prostate Cancer

Interventions

MRI guided prostate biopsy and TRUS guided biopsyDEVICE

MRI guided prostate biopsy

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Urology

Düsseldorf, Germany

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

Time frame: 3 years

Data from ClinicalTrials.gov

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