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临床试验/NCT02326246
NCT02326246已完成不适用

Multi-parametric Magnetic Resonans Imaging in the Diagnosis and Surveillance of Low-risk Prostate Cancer

Aarhus University Hospital Skejby2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2014年10月1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
85
试验地点
2
主要终点
gleason up-grate

研究概览

简要总结

The purpose of this study is to investigate the hypothesis, that mMRI provides a more accurate and secure interpretation of the aggressiveness of prostate cancer initially/before mMRI defined as low risk. In doing so we will investigate and assess the affect of mMRI on gleason score upgrade, risk classification upgrade and changes in treatment strategy (active surveillance vs. operation).

详细描述

At the urological department K, Aarhus University Hospital (AUH), approx. 500 TRUS biopsies are performed each year and about 125 intermediate/high risk patients undergo radical prostatectomy (RP). At any time approx. 50 men with low-risk PC is in active surveillance (AS).

The MRIs will all be performed with a 3 Tesla MRI system with a phased-array coil including standard T1 and T2-weighted sequences, diffusion-weighted sequences with different b-values and a dynamic contrast sequence of the prostate gland. In patients in whom a previous mMRI has shown tumor, the MRGBs will be performed with the commercially available DynaCAD-equipment designed for in-bore MR-guided prostate biopsies.

The Study Design: a prospective study of 60* patients enrolled in an AS program. From late 2014 and approximately one year forward, all patients put in active surveillance after the diagnosis of low risk PC, will after that decision be offered an additional mMRI scan.

If the mMRI gives rise to suspicion of significant cancer, MRGB will be taken. Results of these biopsies will be assessed, and in some cases gleason score will be up-grated, risk classification will be up-grated and the decision to keep the patient in AS will have to be changed, and active treatment will be recommended. If the scan finds no reason to change strategy, the patient will have the usual follow-ups in the clinic, which in an AS program usually consists of control PSA value every 3 months, and new TRUS guided biopsies after 12 months or if PSA rises. Parallel to the usual control program we will perform a new mMRI once a year to assess if there is any progression in the disease, and again do MRGB if this is the case.

The study will require access to the patient journals. We will look at patient demographics, specification on the PC found, histology and blood samples.

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
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age over 18 years
  • PC and put in AC,
  • No contraindications to MRI,
  • Written informed consent

排除标准

  • Lack of ability to consent,
  • Non-MRI compatible metal in the body,
  • Claustrophobia,
  • Heavy obesity (largest circumference more than 180 cm),
  • Moderate/severe kidney malfunction
  • Known allergy to MRI contrast

结局指标

主要结局

gleason up-grate

时间窗: 1 year

次要结局

  • changes in the treatment strategy(1 year)

研究者

发起方
Aarhus University Hospital Skejby
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria C Elkjær

MD, ph.d. student

Aarhus University Hospital Skejby

研究点 (2)

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