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
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