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

Prostate Cancer Clinical Trial

— PROFUSE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450266
• Other study ID #: 004
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2015
• Last updated: May 20, 2015
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: May 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Christian Arsov, MD
• Phone: +49 211 8108607
• Email: christian.arsov[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 586
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• Systematic transrectal ultrasound-guided prostate biopsy
12-18 systematic biopsy cores
• MRI/ultrasound fusion-guided prostate biopsy
2 targeted biopsy cores from each prostate lesion

Locations

Country	Name	City	State
Germany	Department of Urology, Charité-Universitätsmedizin	Berlin
Germany	Department of Urology, University Hospital Düsseldorf	Düsseldorf
Germany	Department of Urology, University Hospital Jena	Jena

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of significant prostate cancers		One week after biopsy	No
Secondary	Overall detection rate of prostate cancers		One week after biopsy	No