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

Heinrich-Heine University, Duesseldorf

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: Systematic transrectal ultrasound-guided prostate biopsy; Device: MRI/ultrasound fusion-guided prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02450266

004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 586 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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586 participants in 2 patient groups

A: Transrectal ultrasound-guided biopsy

Active Comparator group

Description:

Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)

Treatment:

Device: Systematic transrectal ultrasound-guided prostate biopsy

B: MRI/ultrasound fusion-guided biopsy

Experimental group

Description:

Patients of arm B receive a targeted MRI/ultrasound fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.

Treatment:

Device: MRI/ultrasound fusion-guided prostate biopsy