NL-OMON24993尚未招募不适用
Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients (PSMA-Select)
Canisius Wilhelmina Hospital (CWZ)0 个研究点目标入组 546 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 546
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1.>18 years
- •2. Biopsy proven adenocarcinoma of the prostate
- •3. Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram >5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)
- •4. Suitable for robot-assisted ePLND and RARP
- •5. Mentally competent and understanding of benefits and potential burden of the study 5. Written informed consent
- •6. No known allergies for PSMA tracer.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •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 PSMA PET/CT and/or ePLND and RARP
- •4. PSMA non-avid PCa (local tumor activity)
- •5. Presence of distant metastasis (M1)