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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Systematic transrectal ultrasound-guided prostate biopsy
MRI/ultrasound fusion-guided prostate biopsy
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Primary disease, multiparametric MRI, targeted prostate biopsy, MRI/ultrasound fusion-guided prostate biopsy, systematic transrectal ultrasound-guided prostate biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Urology, Charité-UniversitätsmedizinRecruiting
  • Department of Urology, University Hospital DüsseldorfRecruiting
  • Department of Urology, University Hospital JenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A: Transrectal ultrasound-guided biopsy

B: MRI/ultrasound fusion-guided biopsy

Arm Description

Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)

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.

Outcomes

Primary Outcome Measures

Detection rate of significant prostate cancers

Secondary Outcome Measures

Overall detection rate of prostate cancers

Full Information

First Posted
May 19, 2015
Last Updated
May 20, 2015
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Cancer Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02450266
Brief Title
Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy
Acronym
PROFUSE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Cancer Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Primary disease, multiparametric MRI, targeted prostate biopsy, MRI/ultrasound fusion-guided prostate biopsy, systematic transrectal ultrasound-guided prostate biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
586 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Transrectal ultrasound-guided biopsy
Arm Type
Active Comparator
Arm Description
Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)
Arm Title
B: MRI/ultrasound fusion-guided biopsy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Systematic transrectal ultrasound-guided prostate biopsy
Intervention Description
12-18 systematic biopsy cores
Intervention Type
Device
Intervention Name(s)
MRI/ultrasound fusion-guided prostate biopsy
Intervention Description
2 targeted biopsy cores from each prostate lesion
Primary Outcome Measure Information:
Title
Detection rate of significant prostate cancers
Time Frame
One week after biopsy
Secondary Outcome Measure Information:
Title
Overall detection rate of prostate cancers
Time Frame
One week after biopsy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Arsov, MD
Phone
+49 211 8108607
Email
christian.arsov@med.uni-duesseldorf.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Arsov, MD
Organizational Affiliation
Department of Urology, University Hospital Düsseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Charité-Universitätsmedizin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurt Miller, MD
Phone
+49 30 8445 2575
Facility Name
Department of Urology, University Hospital Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Arsov, MD
Phone
+49 211 8108607
Email
christian.arsov@med.uni-duesseldorf.de
Facility Name
Department of Urology, University Hospital Jena
City
Jena
ZIP/Postal Code
07743
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc O Grimm, MD
Phone
+49 3641-935206

12. IPD Sharing Statement

Learn more about this trial

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

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