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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Systematic transrectal ultrasound-guided prostate biopsy
* Device: MRI/ultrasound fusion-guided prostate biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: Transrectal ultrasound-guided biopsy<br>Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume) | Device: Systematic transrectal ultrasound-guided prostate biopsy<br>* 12-18 systematic biopsy cores<br>|
| Experimental: B: MRI/ultrasound fusion-guided biopsy<br>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. | Device: MRI/ultrasound fusion-guided prostate biopsy<br>* 2 targeted biopsy cores from each prostate lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of significant prostate cancers |  | One week after biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall detection rate of prostate cancers |  | One week after biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary disease, multiparametric MRI, targeted prostate biopsy, MRI/ultrasound fusion-guided prostate biopsy, systematic transrectal ultrasound-guided prostate biopsy