Optimizing the Number of Systematic COres During a MRI Target Biopsy

NCT ID: NCT04183699

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2025-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRI targeted + systematic random biopsy

Group Type: EXPERIMENTAL

Prostate biopsy

Intervention Type: DIAGNOSTIC_TEST

MRI-targeted + systematic random prostate biopsy

Interventions

Prostate biopsy

MRI-targeted + systematic random prostate biopsy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Prof. Alberto Briganti

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Armando Stabile

Role: CONTACT

stabile.armando@hsr.it

+390226435660

Lucia Dambrosio

Role: CONTACT

dambrosio.lucia@hsr.it

+390226435660

Facility Contacts

Lucia Dambrosio

Role: primary

dambrosio.lucia@hsr.it

+390226435660

Other Identifiers

SCOT

Identifier Type: -

Identifier Source: org_study_id