Optimizing the Number of Systematic COres During a MRI Target Biopsy

IRCCS San Raffaele126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

126

Conditions

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: through study completion, an average of 1 year

Secondary Outcomes

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

The proportion of men diagnosed with csPCa according to the addition of any single systematic core