Prostate Cancer
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTMRI (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.
Sponsors
Superior University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Pakistan
Outcome results
None listed