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

NCT07048613 — Active not recruiting, 120 participants, Superior University

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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

Registry	NCT07048613
Status	Active not recruiting
Study type	Observational
Enrollment	120 (Actual)
Sponsor	Superior University (Other)
Conditions	Prostate Cancer
Interventions	MRI (mpMRI) (Diagnostic test)
Dates	start 2025-03-17, primary completion 2025-07-01 (estimated), completion 2026-02-25 (estimated), first posted 2025-07-02, last updated 2025-07-02
Locations	1 site in Pakistan

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
MRI (mpMRI)		Diagnostic Test: MRI (mpMRI)

MRI (mpMRI) (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.

+Outcome measures

Primary outcomes

EORTC QLQ-C30 [12 Months]: The EORTC QLQ-C30 is a 30-item questionnaire used to assess the quality of life (QoL) of cancer patients. It consists of five functional scales, three symptom scales, a global health status/QoL scale, and six single-item symptom scales. Scoring involves calculating the average of items within each scale, then linearly transforming the scores to a 0-100 range, with higher scores generally indicating better functioning or higher symptom burden

+Eligibility

Sex: Male, ages: 40 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Aznostics The Diagnostic Center	Lahore	Pakistan