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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Device: Systematic transrectal ultrasound-guided prostate biopsy; Device: MRI/ultrasound fusion-guided prostate biopsy

• Registration Number: NCT02450266
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2015-02
• Status Verified: 2015-05
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Last Update Submitted: 2015-05-20
• Study First Posted: 2015-05-21
• Last Update Posted: 2015-05-21
• Primary Completion: 2017-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 586

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Transrectal ultrasound-guided biopsy	Systematic transrectal ultrasound-guided prostate biopsy	Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)
B: MRI/ultrasound fusion-guided biopsy	MRI/ultrasound fusion-guided prostate 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.

Primary Outcome Measures

Name	Time	Method
Detection rate of significant prostate cancers	One week after biopsy

Secondary Outcome Measures

Name	Time	Method
Overall detection rate of prostate cancers	One week after biopsy

Trial Locations

Locations (3)

Department of Urology, Charité-Universitätsmedizin; 🇩🇪 Berlin, Germany

Department of Urology, University Hospital Düsseldorf; 🇩🇪 Düsseldorf, Germany

Department of Urology, University Hospital Jena; 🇩🇪 Jena, Germany