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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-02-25

Brief Summary

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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.

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Detailed Description

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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

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Prostate Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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MRI (mpMRI)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Male patients who are 40 years of age or older
* Individuals who exhibit increased PSA values (e.g., PSA \>4 ng/mL) or abnormal results on a digital rectal examination (DRE), which are clinical indicators of prostate cancer) 16

Exclusion Criteria

* Individuals who have previously had treatment for prostate cancer, such as hormone therapy, chemotherapy, radiation, or surgery
* Severe comorbidities that make safe imaging or biopsy impossible, such as severe heart failure or end-stage renal disease

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No