MR-targeted vs. Random TRUS-guided Prostate Biopsy

Study Overview
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Brief Summary
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To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be randomized (1:1) into the two study arms.

Detailed Description
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In men with previously negative prostate biopsy and persistent elevated PSA value, it is unclear which biopsy strategy offers the highest detection rate for significant PCa. The hypothesis of this study is that MR-targeted biopsy improves the detection rates of significant prostate cancers compared with systematic TRUS-guided prostate biopsy. Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values (> 4 ng/ml) will be submitted to a multiparametric MR imaging examination of the prostate. Subsequently, participants with suspected regions at MR imaging will be randomized (1:1) into the two study arms. In study arm A patients will be submitted to MR-targeted in-bore prostate biopsy based on the multiparametric MR imaging findings. In study arm B patients will be submitted to systematic TRUS-guided prostate biopsy with saturation scheme.

Official Title
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MR-targeted vs. Random TRUS-guided Prostate Biopsy in Patients With High PSA Values and Previous Negative Biopsy Results: A Randomized Controlled Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: MR-guided in-bore prostate biopsy
* Device: TRUS-guided prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men aged 50-80 at least one negative TRUS-guided prostate biopsy PSA > 4 ng/ml at least one suspected region detected at multiparametric MR imaging signed informed consent Exclusion Criteria: known prostate cancer diagnosis contraindication against MR imaging or uncooperative patients

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: MR-targeted biopsy<br>Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MR imaging two targeted biopsy cores will be taken. | Device: MR-guided in-bore prostate biopsy<br>* 2 targeted biopsy cores from each prostate lesion detected at multiparametric MR imaging<br>|
| Experimental: TRUS-guided biopsy<br>Patients of arm B receive a saturation TRUS-guided prostate biopsy. | Device: TRUS-guided prostate biopsy<br>* 24-28 systematic biopsy core (saturation scheme)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate cancer detection rate |  | within the 3 months after MR imaging | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiparametric magnetic resonance imaging, MR-targeted prostate biopsy, saturation TRUS-guided prostate biopsy