Optimizing the Number of Systematic COres During a MRI Target Biopsy
Key facts
- Who runs it
- IRCCS San Raffaele
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 126 people enrolled
- Started
- 6 Jun 2019
- Ended
- 3 Jun 2026
- Type of study
- Interventional
- Treatments tested
- Prostate biopsy
- Record updated
- 10 June 2026
- Why it stopped
- The study was prematurely terminated due to recruitment challenges, insufficient enrollment, operational constraints, and the inability to generate a sufficiently robust dataset to address the study objectives
Who can take part
- Age
- 18 years to 80 years
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- MRI targeted + systematic random biopsyTreatment being tested
Treatment: Prostate biopsy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Identifying the Optimal Biopsy Scheme at MRI Target Biopsy
- Record updated
- 10 June 2026