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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:
For patients with a PI-RADS score of 3, the diagnosis of prostate cancer is still use prostate biopsy, but the detection rates of prostate cancer and clinically significant prostate cancer are approximately 30% and 15%. It can be seen that most patients with PI-RADS 3 undergo unnecessary prostate biopsy and bear the risk of complications such as urinary tract infection. This makes most patients with PI-RADS 3 choose to refuse invasive prostate biopsy. Although researchers are committed to exploring biomarkers with high sensitivity and specificity, the application of biomarkers alone often cannot achieve the expected results. At present, the guidelines have recommended the use of diagnostic prediction models to assess patients' prostate cancer risk. Doctors and patients use diagnostic models to assess the risk of prostate cancer before prostate biopsy. For patients with a low probability of cancer, biopsy can be temporarily avoided, which to a certain extent reduces the phenomenon of prostate cancer overdiagnosis. This study plans to work with multiple medical centers to conduct statistical analysis based on existing prostate cancer screening markers combined with patients' clinical data such as prostate volume, prostate-specific antigen density, apparent diffusion coefficient, PI-RADS score and postoperative Gleason score, and then construct a prostate cancer diagnostic model to improve the diagnostic accuracy of prostate cancer for patients with PI-RADS score of 3. This will be of great significance for improving the early diagnosis of patients with PI-RADS 3 and reducing unnecessary prostate puncture biopsies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with clinical suspicion of prostate cancer and have PI-RADS score of 3 | Patients with clinical suspicion of prostate cancer (see inclusion criteria) and have PI-RADS score (results of mpMRI) of 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prostate biopsy | Procedure | All patients were required to underwent transperineal prostate biopsy and have corresponding pathological diagnosis results. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Multivariate logistic regression analyses and calculate the odds ratios (95% confidence interval ) of the clinical variables for clinically significant prostate cancer | The clinically significant prostate cancer was defined as Gleason score ≥ 3+4 | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Validation by calculating the C-statistics, drawing ROC curves (AUC values) and calibration curves. | Evaluate the discrimination and calibration of the model constructed by logistic regression analyses | through study completion, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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This is a multicenter retrospective study. All enrolled patients were clinically suspected of prostate cancer (abnormal serum PSA level or DRE), had an indication for prostate biopsy and eventually underwent prostate biopsy. Before biospy, patients also need to complete mpMRI examination, the examination sequence includes at least multi-plane T2WI and multi-b value DWI, and the final patient PI-RADS score needs to be 3.
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| Name | Affiliation | Role |
|---|---|---|
| Jun Xiao, Pro. | The First Affiliated Hospital of USTC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | 233000 | China | ||
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Department of Urology, The First Affiliated Hospital of USTC |
| Hefei |
| Anhui |
| 230001 |
| China |
| Department of Urology, The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | 241000 | China |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |