Optimizing the Number of Systematic COres During a MRI Target Biopsy

NCT04183699 | Recruiting

• 1 other identifier: SCOT
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

MRI targeted + systematic random biopsy

EXPERIMENTAL

Diagnostic Test: Prostate biopsy

Interventions

Prostate biopsy DIAGNOSTIC_TEST

MRI-targeted + systematic random prostate biopsy

MRI targeted + systematic random biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Central Study Contacts

Armando Stabile

CONTACT

+390226435660; stabile.armando@hsr.it

Lucia Dambrosio

CONTACT

+390226435660; dambrosio.lucia@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: December 3, 2019
• Study Start: June 6, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

IT (1)