Clinical trial · Interventional
Optimizing the Number of Systematic COres During a MRI Target Biopsy
Identifying the Optimal Biopsy Scheme at MRI Target Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI targeted + systematic random biopsy
- interventionNames
- Diagnostic Test: Prostate biopsy
Primary outcomes (1)
- measure
- Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy
- timeFrame
- through study completion, an average of 1 year
- description
- Proportion of patients diagnosed with csPCa with 6-core vs. 20-core systematic biopsy during a MRI target biopsy
Secondary outcomes (1)
- measure
- Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsy
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available