NCT04183699

Optimizing the Number of Systematic COres During a MRI Target Biopsy

Identifying the Optimal Biopsy Scheme at MRI Target Biopsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Prostate biopsy	MRI-targeted + systematic random prostate biopsy

Timeline

• Start date: 2019-06-06
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2019-12-03
• Last updated: 2024-06-12

Locations

1 site across 1 country: Italy