CTRI/2024/03/064175尚未招募不适用
Clinical utility of combining Prostate Health Index with multiparametric MRI for diagnosis of prostate cancer with grey zone PSA levels
Christian Medical College, Vellore1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2024年3月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- To determine the performance of Prostate Health Index combined with MRI for
研究概览
简要总结
The study is to assess the sensitivity and specificity of combining a PSA-derived Prostate health index and multiparametric MRI of prostate inpatients whose PSA levels are inconclusive against the gold standard test of TRUS biopsy. In this way, we tend to ensure that these patients aren’t missed out.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients with PSA levels of 4-10 ng/ml, even those detected at surveillance.
排除标准
- •Patients who have cardiac pacemakers, Patients who have metallic implants in any part of the body, Extracapsular prostatic cancer on MpMRI Prostatitis, Prior TURP, Patients on 5α reductase inhibitors within the last three months, Patients who have coagulation disorders, Patients who had received prior hormonal therapy.
结局指标
主要结局
To determine the performance of Prostate Health Index combined with MRI for
时间窗: At the time of diagnosis
the diagnosis of prostate cancer and clinically significant prostate cancer in
时间窗: At the time of diagnosis
patients with grey zone PSA levels
时间窗: At the time of diagnosis
次要结局
- 1. To determine the best threshold for PHI in Southeast Asian population in patients with PSA levels of 4-10 ng/ml(2. To determine the performance of other PSA variables like PSA density, free PSA, free/total PSA ratio, p2PSA, p2PSA/fPSA ratio, PHI density for the diagnosis of prostate cancer and clinically significant prostate cancer in)
研究者
Muhamed Tajudeen
Christian Medical College
研究点 (1)
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