Optimizing the Number of Systematic COres During a MRI Target Biopsy

San Donato Group (GSD)

Status: Enrolling

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

Treatments: Diagnostic Test: Prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04183699

SCOT

Details and patient eligibility

About

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.

Enrollment: 265 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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265 participants in 1 patient group

MRI targeted + systematic random biopsy

Experimental group

Treatment:

Diagnostic Test: Prostate biopsy