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

Sponsors

Lead sponsor: Heinrich-Heine University, Duesseldorf

Collaborator: German Cancer Research Center

Source Heinrich-Heine University, Duesseldorf
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.

Overall Status Unknown status
Start Date February 2015
Completion Date February 2018
Primary Completion Date February 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Detection rate of significant prostate cancers One week after biopsy
Secondary Outcome
Measure Time Frame
Overall detection rate of prostate cancers One week after biopsy
Enrollment 586
Condition
Intervention

Intervention type: Device

Intervention name: Systematic transrectal ultrasound-guided prostate biopsy

Description: 12-18 systematic biopsy cores

Arm group label: A: Transrectal ultrasound-guided biopsy

Intervention type: Device

Intervention name: MRI/ultrasound fusion-guided prostate biopsy

Description: 2 targeted biopsy cores from each prostate lesion

Arm group label: B: MRI/ultrasound fusion-guided biopsy

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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Christian Arsov, MD Principal Investigator Department of Urology, University Hospital Düsseldorf
Overall Contact

Last name: Christian Arsov, MD

Phone: +49 211 8108607

Email: [email protected]

Location
facility status contact
Department of Urology, Charité-Universitätsmedizin Recruiting Kurt Miller, MD +49 30 8445 2575
Department of Urology, University Hospital Düsseldorf Recruiting Christian Arsov, MD +49 211 8108607 [email protected]
Department of Urology, University Hospital Jena Recruiting Marc O Grimm, MD +49 3641-935206
Location Countries

Germany

Verification Date

May 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A: Transrectal ultrasound-guided biopsy

Arm group type: Active Comparator

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

Arm group label: B: MRI/ultrasound fusion-guided biopsy

Arm group type: Experimental

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.

Acronym PROFUSE
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov