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Completed

NCT Number: NCT06507462

A Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Department of Urology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with clinically suspected prostate cancer (abnormal PSA level or DRE);
  • All patients have undergone mpMRI and have complete imaging data;
  • The PI-RADS score of patients was 3;
  • Prostate biopsy was performed and has clear pathological results.

Exclusion criteria

  • The patient's serum tPSA is <4ng/ml or >100ng/ml;
  • Repeated prostate biopsy;
  • The patient's clinical, imaging, or pathological data are incomplete.

Treatment and study plan

Prostate biopsy

Procedure

All patients were required to underwent transperineal prostate biopsy and have corresponding pathological diagnosis results.

Primary outcomes

  1. Multivariate logistic regression analyses and calculate the odds ratios (95% confidence interval ) of the clinical variables for clinically significant prostate cancer

    Time frame: through study completion, an average of 3 months

    The clinically significant prostate cancer was defined as Gleason score ≥ 3+4

Secondary outcomes

  1. Validation by calculating the C-statistics, drawing ROC curves (AUC values) and calibration curves.

    Time frame: through study completion, an average of 3 months

    Evaluate the discrimination and calibration of the model constructed by logistic regression analyses

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

Construction and Validation of a Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3: a Multicenter, Retrospective Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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