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临床试验/NCT02232685
NCT02232685已完成不适用

Whole Body Bone Scan vs 18F-Choline PET/CT, Better Detection of Bone Metastases in Prostate Cancer Patients, PROSTAGE I

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
2
主要终点
Metastases to bone (yes/no)

研究概览

简要总结

Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world. Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods for staging are known to be inaccurate. Prior studies from our department suggest that PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of this study is to test the usefulness of Choline PET/CT for the staging of bone metastases compared to current standard methods in patients with newly diagnosed prostate cancer.

Better initial staging will result in better treatment of the individual patient. If we are able to develop a more accurate method of staging patients with undetected metastases on current staging will be spared of the side-effects associated with current treatment - impotence, incontinence, radiation damage etc.

详细描述

  1. Introduction. Cancer of the prostate (PCa) is currently the leading newly diagnosed cancer and the second most common cause of cancer deaths among men in the industrialized world . In Denmark alone more than 4000 men are yearly diagnosed with PCa . As PCa primarily affects elderly patients, one can assume that PCa will become one of the most important medical issues in the developed world due to the already high incidence combined with a growing population of elderly men.

The aetiology of the disease is not well understood. In its most common form PCa evolves from the glandular tissue of the prostate. Metastatic spread will most commonly happen as lymphogenous spread to the regional lymph nodes or as haematogenous spread to the red bone marrow .

Intended curative treatment of PCa is associated with considerable side effects, in particular incontinence, impotence and radiation damage to the surrounding tissues. Furthermore, over 30% of patients with organ-confined disease, which was treated with radical prostatectomy, will have biochemical relapse within 10 years . Relapse may be due to local recurrent disease suggesting poor surgical quality or poor initial staging with undetected metastases at the time of treatment.

At diagnosis patients are stratified as having low, intermediary or high risk of dissieminatio according to D'Amico. Patients with intermediate or high risk of dissemination will be examined further with whole-body bone scintigraphy (WBS) and pelvic lymph node dissection (PLND). 2. Background. 2.1. Current staging and limitations. WBS has been the examination of choice for evaluation of potential dissemination to bone. WBS utilizes 99mTc-labeled methylene diphosphonate (99mTc-MDP) that binds to the bone matrix formed by the osteoblasts. Gamma cameras detect the γ-radiation emitted by the decaying tracer thereby creating a 2-dimentional image depicting local osteoblast activity .

Several limitations apply to the use of WBS in staging of patients with PCa. Sensitivity has reported as low as 39% in lesion-based analysis in patients with a low number of lesions . This combines with a low sensitivity due to many equivocal lesions caused by other bone pathology than metastasis.

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

性别
Male
接受健康志愿者

入选标准

  • Newly diagnosed, histologically verified PCa and
  • Written consent and
  • PSA ≥ 20 ng/mL and/or
  • Gleason score > 6 and/or
  • cT-stage ≥ cT2c

排除标准

  • Withdrawal of consent or
  • Other active malign disease

结局指标

主要结局

Metastases to bone (yes/no)

时间窗: 1 day (At the time of scan interpretation)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mike Allan Mortensen

MD

Odense University Hospital

研究点 (2)

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