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).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 742
- 试验地点
- 17
- 主要终点
- Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml.
研究概览
简要总结
To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended pelvic lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable (non-inferior) disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk >5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Psma-select Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Age ≥18 years
- •Biopsy proven adenocarcinoma of the prostate
- •Indication for ePLND combined with RARP
- •Suitable for robot-assisted ePLND + RARP 5.. Mentally competent and understanding of benefits and potential burden of the study
- •Written informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •History of prior diagnosed or treated PCa
- •Known concomitant malignancies (except Basal Cell Carcinoma of the skin) 3.Unwillingness or inability to undergo PSMA PET/CT and/or ePLND
- •PSMA non-avid PCa (local tumor activity)
- •Presence of distant metastasis (M1)
结局指标
主要结局
Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml.
Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml.
次要结局
- - Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs, costs of complication-related interventions and associated (prolonged) hospital stay. - Biochemical persistence, defined as PSA >0.1 within half a year after surgery - Surgical complications within 6 months after surgery. - Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template. The necessity for a second PSMA PET / CT.
研究者
Liselot Ribbert
Scientific
Canisius Wilhelmina Ziekenhuis