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Optimizing the Number of Systematic COres During a MRI Target Biopsy

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ClinicalTrials.gov Identifier: NCT04183699
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Alberto Briganti, IRCCS San Raffaele

Study Description
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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.

Condition or disease Intervention/treatment Phase
Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate Diagnostic Test: Prostate biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 265 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identifying the Optimal Biopsy Scheme at MRI Target Biopsy
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MRI targeted + systematic random biopsy Diagnostic Test: Prostate biopsy
MRI-targeted + systematic random prostate biopsy


Outcome Measures
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Primary Outcome Measures :
  1. Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy [ Time Frame: 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 :
  1. Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsybiopsy [ Time Frame: through study completion, an average of 1 year ]
    The proportion of men diagnosed with csPCa according to the addition of any single systematic core


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183699


Contacts
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Contact: Marta Picozzi +390226436268 picozzi.marta@hsr.it

Locations
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Italy
IRCCS San Raffaele Recruiting
Milan, Italy, 20132
Contact: Marta Picozzi    +390226436268    picozzi.marta@hsr.it   
Principal Investigator: Alberto Briganti, Prof         
Sub-Investigator: Armando Stabile, MD         
Sub-Investigator: Francesco Pellegrino, MD         
Sponsors and Collaborators
IRCCS San Raffaele
More Information
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Responsible Party: Prof. Alberto Briganti, Full Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04183699    
Other Study ID Numbers: SCOT
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases