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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: prostate biopsy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 460

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233000
      • Department of Urology, The First Affiliated Hospital of Bengbu Medical University
    • Hefei, Anhui, China, 230001
      • Department of Urology, The First Affiliated Hospital of USTC
    • Wuhu, Anhui, China, 241000
      • Department of Urology, The First Affiliated Hospital of Wannan Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: prostate biopsy; All patients were required to underwent transperineal prostate biopsy and have corresponding pathological diagnosis results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Principal Investigator: Jun Xiao, Pro., The First Affiliated Hospital of USTC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Prostate cancer; Diagnosis; Predictive model; Prostate Imaging-Reporting and Data System
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2024-ky312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No