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临床试验/NCT05612204
NCT05612204已完成不适用

Evaluation of Targeted Prostate Biopsies Under MRI: Tolerance and Contribution in the Therapeutic Decision - Exploratory Study

GCS Ramsay Santé pour l'Enseignement et la Recherche3 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2022年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
3
主要终点
Type of care offered in multidisciplinary consultation meeting

研究概览

简要总结

The goal of this clinical trial is to assess the concordance of treatment decisions made in multidisciplinary consultation meeting based on targeted biopsies alone or targeted biopsies associated with systematic biopsies in patients with suspected prostate cancer.

详细描述

Prostate cancer is the most common cancer in France and is the third most common cancer death in men.

Early detection is based on family and ethnic history, digital rectal examination and total PSA testing. It is done at age 50 for the general population but is restricted to men with an estimated survival of more than 10 years.

In case of clinical suspicion of prostate cancer, the diagnosis is based on the realization of prostate biopsies. Until recently, 12 so-called "systematic" (BS) biopsies were performed under ultrasound control, according to a standardized protocol, which allowed sampling of the entire prostate.

Since the latest recommendations of the French Association of Urology in 2020, an MRI is systematically indicated before performing biopsies. Indeed, MRI is a sensitive technique that will increase the suspicion of significant prostate cancer. An MRI is considered "positive" if at least one suspicious area with a PI-RADS score ≥ 3 is detected. In this case, the French Association of Urology recommends performing so-called targeted biopsies (BC) on these suspicious areas associated with the 12 SBs.

From a technical point of view, ultrasound is the reference examination for performing targeted biopsies on suspicious lesions detected on MRI, either by visual guidance (cognitive identification) or by image fusion techniques, MRI and ultrasound.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patient, male, aged between ≥ 50 and ≤ 75 years old
  • Patient with no history of prostate biopsy
  • Patient with a PSA greater than 4 and/or a pathological digital rectal examination
  • Patient having an MRI of interpretable quality carried out within the HPA
  • Patient with a single lesion with a PI-RADS score ≥ 3
  • Affiliated patient or beneficiary of a social security scheme
  • French-speaking patient who signed an informed consent

排除标准

  • Patient with a contraindication to MRI
  • Patient with multiple targets
  • Patient with lesions with PI-RADS score 1 and 2
  • Patient on long-term anticoagulants and unable to stop it
  • Patient already included in another study
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Patient hospitalized without consent

研究组 & 干预措施

Biopsy under MRI

Experimental

干预措施: Biopsy under MRI (Procedure)

结局指标

主要结局

Type of care offered in multidisciplinary consultation meeting

时间窗: 2 MONTHS

次要结局

未报告次要终点

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (3)

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