A Prospective Randomized Study Comparing the Diagnostic Efficacy of MR-guided in Bore Prostate Biopsy Versus MRI/US Fusion-guided Prostate Biopsy in Men With at Least One Negative Prostate Biopsy

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

Sponsors

Lead sponsor: Heinrich-Heine University, Duesseldorf

Source 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.

Overall Status Completed
Start Date November 2011
Completion Date October 2014
Primary Completion Date August 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Prostate cancer detection rate 1 week after biopsy
Enrollment 480
Condition
Intervention

Intervention type: Device

Intervention name: MR-guided in-bore prostate biopsy

Description: 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.

Arm group label: A: MR-guided in-bore prostate biopsy

Intervention type: Device

Intervention name: MRI/US fusion-guided prostate biopsy

Description: 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)

Arm group label: B: MRI/US fusion-guided prostate biopsy

Eligibility

Criteria:

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

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 of Düsseldorf
Location
facility
University Hospital Düsseldorf
Location Countries

Germany

Verification Date

March 2015

Responsible Party

Responsible party type: Sponsor

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

Arm group label: A: MR-guided in-bore prostate biopsy

Arm group type: Experimental

Description: 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.

Arm group label: B: MRI/US fusion-guided prostate biopsy

Arm group type: Experimental

Description: 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)

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov