Optimizing the Number of Systematic COres During a MRI Target Biopsy

Summary

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.

Eligibility

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

Conditions2

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