Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: MRI/US fusion-guided prostate biopsy; Device: MR-guided in-bore prostate biopsy

• Registration Number: NCT02220517
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more prostate cancers than targeted MR-guided in-bore prostate.

Detailed Description

In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which strategy offers the highest detection rate for prostate cancer. The hypothesis of this study is that targeted MRI-guided biopsy combined with transrectal ultrasound (TRUS)-guided biopsy may potentially detect more cancers than MRI-guided prostate biopsies alone.

Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values 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 targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI-guided in-bore prostate biopsy. In study arm B targeted biopsies will be performed using MRI/TRUS-fusion-guided prostate biopsy with software-registration (MRI/TRUS image fusion). Patients of study arm B undergo additional systematic 12-core TRUS-guided prostate biopsy.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2014-07-07
• Primary Completion: 2014-08
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-20
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 480

Inclusion Criteria

• At least one prior negative prostate biopsy
• Prostate-specific antigen (PSA) > 4 ng/ml

Exclusion Criteria

• Known prostate cancer
• Contraindications against MRI
• Contraindications against prostate biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: MRI/US fusion-guided prostate biopsy	MRI/US fusion-guided prostate biopsy	Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)
A: MR-guided in-bore prostate biopsy	MR-guided in-bore prostate biopsy	Patients of arm A receive a targeted MR-guided in-bore 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
Prostate cancer detection rate	1 week after biopsy

Trial Locations

Locations (1)

University Hospital Düsseldorf; 🇩🇪 Düsseldorf, Germany