Clinical trial NCT02450266: Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Primary disease
multiparametric MRI
targeted prostate biopsy
MRI/ultrasound fusion-guided prostate biopsy
systematic transrectal ultrasound-guided prostate biopsy
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
First posted: 2015-05-21
Enrollment: 586
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Detection rate of significant prostate cancers
timeFrame: One week after biopsy
Secondary outcomes:
measure: Overall detection rate of prostate cancers
timeFrame: One week after biopsy
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Urology, Charité-Universitätsmedizin
city: Düsseldorf
country: Germany
facility: Department of Urology, University Hospital Düsseldorf
city: Jena
country: Germany
facility: Department of Urology, University Hospital Jena
Study officials:
affiliation: Department of Urology, University Hospital Düsseldorf
name: Christian Arsov, MD
role: PRINCIPAL_INVESTIGATOR
References: