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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- EORTC QLQ-C30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
EORTC QLQ-C30
时间窗: 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
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University