EUCTR2019-004045-33-NL进行中（未招募）1 期
PredicTive value of FluoR-18 PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT before PLND for lymph nodE staging in primary pRostate cancer - TRACER
Catharina Hospital Eindhoven0 个研究点目标入组 70 人开始时间: 2020年9月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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. Biopsy proven adenocarcinoma of the prostate;
- •2. Indication for (super)extended PLND (with or without (robot-assisted) laparoscopic prostatectomy), in intermediate and high risk patients ( d’Ámico score) with an MSKCC >5% lymph node prediction;
- •3. Mentally competent and understanding of benefits and potential burden of the study;
- •4. Written informed consent;
- •5. Age =18 years.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. History of prior diagnosed or treated PCa.
- •2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin).
- •3. Unwillingness or inability to undergo 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT, in combination with PLND.
- •4. Metastasis beyond pelvic region and/or bone metastasis. Patients with bone metastasis will not get a PLND, but will be included in the study for further follow-up.
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