Optimizing the Number of Systematic COres During a MRI Target Biopsy

Not Applicable

Recruiting

• Conditions: Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate
• Interventions: Diagnostic Test: Prostate biopsy

• Registration Number: NCT04183699
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 265

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI targeted + systematic random biopsy	Prostate biopsy	-

Primary Outcome Measures

Name	Time	Method
Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy	through study completion, an average of 1 year	Proportion of patients diagnosed with csPCa with 6-core vs. 20-core systematic biopsy during a MRI target biopsy

Secondary Outcome Measures

Name	Time	Method
Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsy	through study completion, an average of 1 year	The proportion of men diagnosed with csPCa according to the addition of any single systematic core

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, Italy