NCT07048613

Comparative Study of MRI and TU in Identifying Clinically Significant Prostate Cancer Among Ethnic Groups

Comparative Study of Magnetic Resonance Imaging and Transrectal Ultrasound in Identifying Clinically Significant Prostate Cancer Among Diverse Ethnic Groups Using Histopathology as the Gold Standard

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Superior University · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Transrectal Ultrasound (TRUS) in detecting clinically significant prostate cancer, using histopathology (biopsy results) as the gold standard. Prostate cancer is a leading cause of cancer-related morbidity among men globally, and its detection often varies across ethnic groups due to genetic, environmental, and healthcare access factors. This research aims to evaluate how MRI and TRUS perform across diverse ethnic populations to determine the most reliable imaging modality for early diagnosis.

Detailed description

The study will follow an observational, cross-sectional design. Patients suspected of having prostate cancer will undergo both MRI and TRUS imaging before a prostate biopsy. Imaging findings will be recorded and compared to the histopathological outcomes from biopsy samples. Sensitivity, specificity, positive predictive value, and negative predictive value will be calculated for each modality. Additionally, subgroup analysis will be performed to evaluate performance variations across different ethnic groups.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI (mpMRI)	: Combines T2-weighted imaging, Diffusion-weighted imaging (DWI), and Dynamic contrast-enhanced MRI (DCE-MRI) to provide detailed anatomical images and assess tissue characteristics.

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-07-01
• Completion: 2026-02-25
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: Pakistan