Clinical trial · Observational
VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE BIOPSY
VALIDATION OF THE FUSION CEMEP SCORE FOR THE OMISSION OF SYSTEMATIC PROSTATE BIOPSY IN PATIENTS UNDERGOING MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING-TARGETED BIOPSY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to prospectively validate the Fusion CEMEP score to assess the safety and efficacy of omitting systematic prostate biopsy in patients undergoing multiparametric magnetic resonance imaging-targeted biopsy. The main objective is to determine if target-only biopsy guided by the score is sufficient for clinically significant prostate cancer detection while reducing overtreatment and unnecessary cores.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms/Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FUSION CEMEP SCORE STRATEGY | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT
- description
- Patients evaluated with multiparametric MRI-targeted biopsy using the Fusion CEMEP score.
- interventionNames
- Other: FUSION CEMEP SCORE STRATEGY
Primary outcomes (1)
- measure
- DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER
- timeFrame
- AT THE TIME OF PROSTATE BIOPSY (WITHIN 30 DAYS OF EVALUATION)
- description
- Percentage of patients diagnosed with clinically significant prostate cancer (Gleason score \>= 7) using the target-only biopsy guided by the Fusion CEMEP score compared to the full systematic scheme.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult male patients with clinical suspicion of prostate cancer. * Patients scheduled to undergo multiparametric MRI-targeted prostate biopsy. * Signed informed consent. Exclusion Criteria: * Prior treatment for prostate cancer. * Contraindications to prostate biopsy or multiparametric MRI.
References
Publications (0)
Data not yet available