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

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: MRI/US fusion-guided prostate biopsy; Device: MR-guided in-bore prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02220517

003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

A: MR-guided in-bore prostate biopsy

Experimental group

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.

Treatment:

Device: MR-guided in-bore prostate biopsy

B: MRI/US fusion-guided prostate biopsy

Experimental group

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)

Treatment:

Device: MRI/US fusion-guided prostate biopsy