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临床试验/NCT06029088
NCT06029088已完成不适用

Risk-adapted Strategy Combining Magnetic Resonance Imaging and Prostate-specific Antigen Density to Individualize Biopsy Decision in Patients With PI-RADS 3 'Gray Zone' Lesions

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 616 人开始时间: 2023年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
616
试验地点
1
主要终点
Reducing unnecessary prostate biopsy with the combined use of magnetic resonance imaging and prostat-specific antigen density measurement

研究概览

简要总结

Recent guidelines now recommend multi parametric magnetic resonance imaging prior to biopsy for all men as an integral part of improved diagnosis of clinical significant prostate cancer. However, magnetic resonance imaging targeted biopsy is a strategy that focuses on maximizing detection of clinical significant prostate cancer, but this procedure has the disadvantage of leading to higher detection of clinically insignificant prostate cancers. One of the risk-stratifications developed to minimize the existing disadvantages and avoid unnecessary biopsy procedures is a strategy in which multi parametric magnetic resonance imaging and prostate-specific antigen density are used in combination. This is especially important in all patients with PI-RADS (Prostate Imaging Reporting and Data System) 3 lesions which are also interpreted as indeterminate mpMRI findings. Current guidelines suggest that biopsy may be omitted in some patient groups with PI-RADS 3 lesions in the risk-adapted strategy involving prostate-specific antigen density. The aim of this study was to evaluate the role of risk-adapted strategies involving prostate-specific antigen density in biopsy decision to avoid unnecessary biopsy vs the risk of missing clinical significant prostate cancer diagnosis in patients with PI-RADS 3 lesions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients who all had undergone multi parametric magnetic resonance imaging at our hospital
  • Patients who all had undergone transrectal ultrasonography guided cognitive and fusion targeted biopsies

排除标准

  • Magnetic resonance imaging at exterior hospitals
  • Insufficient image quality/artifacts
  • Previous prostate biopsy and/or prior prostate cancer diagnosis

结局指标

主要结局

Reducing unnecessary prostate biopsy with the combined use of magnetic resonance imaging and prostat-specific antigen density measurement

时间窗: 2 weeks from the outpatient clinic admission

次要结局

未报告次要终点

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Cagri Akpinar

M.D.

Ankara Etlik City Hospital

研究点 (1)

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