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

May 20, 2015 updated by: Heinrich-Heine University, Duesseldorf

Prospective Multicenter, Randomized Study Comparing the Diagnostic Efficacy of a Targeted MRI/Ultrasound Fusion-guided Prostate Biopsy Versus a Systematic Transrectal Ultrasound-guided Biopsy in Men With at Least on Negative Prostate Biopsy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of significant prostate cancers compared with systematic transrectal ultrasound-guided prostate biopsy.

Men with at least one previously negative transrectal ultrasound-guided biopsy and persistently elevated PSA values (> 3 ng/ml) or PSA velocity >0.75 ng/ml/p.a. 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. Targeted biopsies will be performed using MRI/ultrasound fusion-guided.

Study Type

Interventional

Enrollment (Anticipated)

586

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Department of Urology, Charité-Universitätsmedizin
        • Contact:
          • Kurt Miller, MD
          • Phone Number: +49 30 8445 2575
      • Düsseldorf, Germany, 40225
      • Jena, Germany, 07743
        • Recruiting
        • Department of Urology, University Hospital Jena
        • Contact:
          • Marc O Grimm, MD
          • Phone Number: +49 3641-935206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • At least one negative transrectal ultrasound-guided prostate biopsy
  • PSA > 3.0 ng/ml or PSA velocity >0.75 ng/ml/p.a.

Exclusion Criteria:

  • Known prostate cancer
  • PSA >50 ng/ml
  • Previous MRI-targeted prostate biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: Transrectal ultrasound-guided biopsy
Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)
Device: Systematic transrectal ultrasound-guided prostate biopsy
12-18 systematic biopsy cores
Experimental: B: MRI/ultrasound fusion-guided biopsy
Patients of arm B receive a targeted MRI/ultrasound fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
Device: MRI/ultrasound fusion-guided prostate biopsy
2 targeted biopsy cores from each prostate lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection rate of significant prostate cancers
Time Frame: One week after biopsy
One week after biopsy

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall detection rate of prostate cancers
Time Frame: One week after biopsy
One week after biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

German Cancer Research Center

Investigators

  • Principal Investigator: Christian Arsov, MD, Department of Urology, University Hospital Düsseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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