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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI (mpMRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-C30 | 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 | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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The primary condition under investigation in this study is clinically significant prostate cancer, a malignant disease affecting the prostate gland in men. The study focuses on the diagnostic evaluation and detection of this condition using two commonly employed imaging techniques: Magnetic Resonance Imaging (MRI) and Transrectal Ultrasound (TRUS).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aznostics The Diagnostic Center | Lahore | Pakistan |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |