Optimizing the Number of Systematic COres During a MRI Target Biopsy

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.

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

Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsybiopsy

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