NCT02450266

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 586 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Systematic transrectal ultrasound-guided prostate biopsy	12-18 systematic biopsy cores
DEVICE	MRI/ultrasound fusion-guided prostate biopsy	2 targeted biopsy cores from each prostate lesion

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2018-02-01
• First posted: 2015-05-21
• Last updated: 2015-05-21

Locations

3 sites across 1 country: Germany