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临床试验/CTRI/2024/10/075192
CTRI/2024/10/075192尚未招募不适用

Comparative analysis of diagnostic performance of P.I.R.A.D.S of bp/mp-MRI of prostate and Intraprostatic SUVmax of PSMA-PET, compared with ISUP Grading of Prostate Biopsy for diagnosing Prostate Cancer in a University Teaching Hospital in Karnataka.

Dr Puppala Vinayaka Vishnu Vardhan1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年10月25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
128
试验地点
1
主要终点
The Data will be analysed to determine if bp/mp-MRI and PSMA PET can predict avoiding a biopsy in patient with clinically significant prostate cancer

研究概览

简要总结

The study will be conducted for a period of two years in Kasturba Hospital, Manipal by the Department of Urology and Renal Transplant, in the following manner.

1)Patients examined in urology OPD suspected of prostate cancer on Digital rectal examination and patients who have been diagnosed or suspected of prostate cancer from other departments are enrolled in study.

2)An informed consent is obtained from patients who fit the inclusion criteria

3)Patients will undergo the following tests as a part of existing protocol in department - a)PSA   b) PIRADS of bp/mp MRI of prostate   c)PSMA PET Scan for PIRADS score >3  d)Prostate biopsy

4)Following values are obtained and analysed for consensus - a) PSA  b) PIRADS   c) Intraprostatic SUVmax  d) ISUP grading

5)Statistical Analyses will be performed by obtaining the following values for ISUP grading PIRADS and intraprostatic SUVmax in diagnosing prostate cancer - a) sensitivity, specificity  b)Negative predictive value, positive predictive vale   c)Likelihood ratio   d)Accuracy of test   e) Area under ROC

  1. The target sample is 128, however due to time restrictions, sample size achieved maybe time bound

  2. In additional to the above data, retrospectively records of patients diagnosed with prostate cancer from the year 2020 will be examined. Patients who have undergone bp/mp-MRI of prostate and PSMA PET CT will be included in the study.

By comparing the diagnostic performance  in detecting prostate cancer of the invasive test of prostate biopsy with the non invasive tests of bp/mp-MRI and PSMA PET scan, a more patient friendly pathway can be achieved towards diagnosing and treating prostate cancer.

研究设计

研究类型
Observational

入排标准

年龄范围
45.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • Patients with suspicion of prostate cancer on digital rectal examination Elevated serum PSA level > 3 ng/dl.

排除标准

  • Patients who have undergone Prostate biopsy, bp/mp-MRI and PSMA-PET elsewhere Coagulopathy Painful anorectal conditions Significant immunosuppression Acute prostatitis Contraindications for MRI Contraindications for PET scan.

结局指标

主要结局

The Data will be analysed to determine if bp/mp-MRI and PSMA PET can predict avoiding a biopsy in patient with clinically significant prostate cancer

时间窗: 2 years

次要结局

  • 1)Accuracy of ISUP Grading of prostatic biopsy alone in detetcting prostate cancer(2)Accuracy of PIRADS of bp/mp-MRI alone in detecting prostate cancer)

研究者

发起方
Dr Puppala Vinayaka Vishnu Vardhan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Puppala Vinayaka Vishnu Vardhan

Department of Urology and Renal Transplant, Kasturba Medical College, Manipal

研究点 (1)

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