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

NCT06507462 | Completed DMC

• 1 other identifier: 2024-ky312
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 3

Brief Summary

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

Prostate Cancer

Keywords

Prostate cancer; Predictive model; Diagnosis; Prostate Imaging-Reporting and Data System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  through study completion, an average of 3 months

Study Arms (1)

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

Interventions

prostate biopsy PROCEDURE

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

Patients with clinical suspicion of prostate cancer and have PI-RADS score of 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (3)

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

Bengbu, Anhui, 233000, China

Location

Department of Urology, The First Affiliated Hospital of USTC

Hefei, Anhui, 230001, China

Location

Department of Urology, The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Xiao, Pro.

  The First Affiliated Hospital of USTC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 18, 2024
• Study Start: January 1, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

CN (3)