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

NCT ID: NCT01553838

Last Updated: 2014-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sequentially MRI guided and TRUS guided biopsy

Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy

Group Type EXPERIMENTAL

MRI guided prostate biopsy and TRUS guided biopsy

Intervention Type DEVICE

MRI guided prostate biopsy

Interventions

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MRI guided prostate biopsy and TRUS guided biopsy

MRI guided prostate biopsy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Arsov, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, University of Duesseldorf

Locations

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Department of Urology

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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