Optimizing the Number of Systematic COres During a MRI Target Biopsy

Study Overview
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Brief Summary
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This is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores). During the same session, subsequently to MRI-TBx, patient will receive a systematic sampling with 6-core S-Bx followed by 14-core S-Bx, for a total of 20-core systematic cores, in addition to 4 MRI-TBx cores. Procedure will be performed by the same operator. Each single core will be stored in a dedicated cassette and sequentially numbered. We hypothesize that the proportion of csPCa (defined as prostate cancer with Gleason score ≥ 3+4) detected by 6-cores S-Bx will be no less than that detected by 20-cores S-Bx, both performed in addition to MRI-TBx. Assessing the optimal number of systematic cores to take in addition to MRI-TBx cores in men undergoing a MRI-TBx would provide a useful clinical information for every day clinical practice. Moreover, the possibility to decrease the number of systematic cores taken during a MRI-TBx, hence reducing the overall number of cores taken during a biopsy, would reduce the length of the diagnostic procedure, potentially reduce the probability of infections/sepsis and reduce the overdiagnosis of clinically insignificant PCa.

Official Title
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Identifying the Optimal Biopsy Scheme at MRI Target Biopsy

Conditions
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Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate

Intervention / Treatment
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* Diagnostic Test: Prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients, aged between 18 and 80 years old with suspicion of prostate cancer Presence of a positive mpMRI of the prostate (visible lesion PI-RADS ≥ 3) Serum PSA ≤ 20ng/ml Suspected stage ≤ T2 on rectal examination (organ confined prostate) Fit to undergo a prostate biopsy Able to understand and willing to sign a written informed consent document Exclusion Criteria: Prior positive prostate biopsy Prior treatment of the prostate Prostate volume <30 ml at mpMRI of the prostate More than one lesion at mpMRI of the prostate Contraindication to prostate biopsy

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI targeted + systematic random biopsy<br> | Diagnostic Test: Prostate biopsy<br>* MRI-targeted + systematic random prostate biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy | Proportion of patients diagnosed with csPCa with 6-core vs. 20-core systematic biopsy during a MRI target biopsy | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsybiopsy | The proportion of men diagnosed with csPCa according to the addition of any single systematic core | through study completion, an average of 1 year |