Clinical trial · Observational
A Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3
Construction and Validation of a Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3: a Multicenter, Retrospective Study
- 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)
The goal of this observational study is to construct a predictive model for improving the diagnostic accuracy in patients with PI-RADS score of 3. The main aims of this study are: * Construct a diagnostic model of patients with PI-RADS of score. * Internal and external validation of the model. * Decision curve analysis. The data of participants was collected retrospectively.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with clinical suspicion of prostate cancer and have PI-RADS score of 3
- description
- Patients with clinical suspicion of prostate cancer (see inclusion criteria) and have PI-RADS score (results of mpMRI) of 3.
- interventionNames
- Procedure: prostate biopsy
Primary outcomes (1)
- measure
- Multivariate logistic regression analyses and calculate the odds ratios (95% confidence interval ) of the clinical variables for clinically significant prostate cancer
- timeFrame
- through study completion, an average of 3 months
- description
- The clinically significant prostate cancer was defined as Gleason score ≥ 3+4
Secondary outcomes (1)
- measure
- Validation by calculating the C-statistics, drawing ROC curves (AUC values) and calibration curves.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with clinically suspected prostate cancer (abnormal PSA level or DRE); 2. All patients have undergone mpMRI and have complete imaging data; 3. The PI-RADS score of patients was 3; 4. Prostate biopsy was performed and has clear pathological results. Exclusion Criteria: 1. The patient's serum tPSA is \<4ng/ml or \>100ng/ml; 2. Repeated prostate biopsy; 3. The patient's clinical, imaging, or pathological data are incomplete.
References
Publications (0)
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