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临床试验/EUCTR2014-003165-15-IT
EUCTR2014-003165-15-IT进行中(未招募)1 期

18F-FACBC PET/CT FOR STAGING HIGH RISK PROSTATE CANCER - FACBC-STAGING-2014

AOU di Bologna Policlinico S.Orsola-Malpighi0 个研究点目标入组 110 人开始时间: 2014年8月27日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
110

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • 1.Subjects with biopsy-proven adenocarcinoma of the prostate
  • 2.Moderate- to high risk prostate cancer as defined by:
  • -Moderate risk: T2b-T2c or Gleason score 7 or PSA 10-20 ng/mL;
  • -High risk: T3a or Gleason score 8-10 or PSA > 20 ng/mL.
  • 3. Staging according to conventional preoperative workup tests (digital rectal examination, transrectal ultrasound, biopsy, likelihood of lymph node metastasis with clinical nomograms, Choline PET/CT)
  • 4. Choline PET/CT negative for bone metastases
  • 5.Surgical plan: prostatectomy with limited or extended lymph node dissection within 40 days from the imaging
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 55
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 55

排除标准

  • 1.Inability to undergo 18F-FACBC PET/CT scanning for any reason.
  • 2.Prior invasive malignancy (except basal cell carcinoma) unless disease-free for a minimum of 3 years
  • 3.Severe acute co-morbidity
  • 4.Specific preoperative therapy (hormonal treatment, chemotherapy, radiotherapy

研究者

发起方
AOU di Bologna Policlinico S.Orsola-Malpighi

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