Optimizing the Number of Systematic COres During a MRI Target Biopsy

Identifying the Optimal Biopsy Scheme at MRI Target Biopsy

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 Overview

• Status: Recruiting
• Conditions: Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate
• Intervention / Treatment: Diagnostic test: Prostate biopsy

• Study Type: Interventional
• Enrollment (Estimated): 265
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucia Dambrosio; Phone Number: +390226435660; Email: dambrosio.lucia@hsr.it
• Study Contact Backup: Name: Armando Stabile; Phone Number: +390226435660; Email: stabile.armando@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS San Raffaele
    • Principal Investigator: Alberto Briganti, Prof
    • Sub-Investigator: Armando Stabile, MD
    • Sub-Investigator: Francesco Pellegrino, MD
    • Contact: Lucia Dambrosio; Phone Number: +390226435660; Email: dambrosio.lucia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI targeted + systematic random biopsy	Diagnostic test: Prostate biopsy; MRI-targeted + systematic random prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SCOT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No