RecruitingNot ApplicableNCT04183699

Optimizing the Number of Systematic COres During a MRI Target Biopsy

Identifying the Optimal Biopsy Scheme at MRI Target Biopsy


Sponsor

IRCCS San Raffaele

Enrollment

265 participants

Start Date

Jun 6, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

Interventions

DIAGNOSTIC_TESTProstate biopsy

MRI-targeted + systematic random prostate biopsy


Locations(1)

IRCCS San Raffaele

Milan, Italy

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NCT04183699