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Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy

NCT02450266 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2015-05-21

No results posted yet for this study

Summary

Patients will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings.

Conditions

Interventions

DEVICE

Systematic transrectal ultrasound-guided prostate biopsy

12-18 systematic biopsy cores

DEVICE

MRI/ultrasound fusion-guided prostate biopsy

2 targeted biopsy cores from each prostate lesion

Sponsors & Collaborators

  • German Cancer Research Center

    collaborator OTHER

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Christian Arsov, MD · Department of Urology, University Hospital Düsseldorf

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-02-28
Completion
2018-02-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02450266 on ClinicalTrials.gov