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

Superior University

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Diagnostic Test: MRI (mpMRI)

Study type: Observational

Funder types: Other

Identifiers

NCT07048613

MSAHSW/Batch-Fall23/901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

MRI (mpMRI)

Treatment:

Diagnostic Test: MRI (mpMRI)