PROMISE Registry on Standardized Evaluation of PSMA-PET and Outcome in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Background:
PROMISE criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET whole-body stage of prostate cancer. PSMA PET disease extent by PROMISE has been associated with oncologic outcome.
Need:
Improved prognostication across various stages of prostate cancer is needed for management guidance and study design.
Aim:
- To assess the prognostic value of PSMA PET
- To compare the prognostic value of PSMA PET with clinical prognostic scores in patients with prostate cancer at various disease stages
Inclusion:
- Adult patients with
- biopsy/histo proven prostate cancer who
- underwent PSMA PET (any type)
- for staging or re-staging at any stage and who
- have at least 3-year overall survival follow-up data available will be included consecutively.
Exclusion:
- Patients with neuroendocrine prostate cancer
- Patients with metastasized or disseminated malignancy other than prostate cancer
详细描述
Background:
Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) Positron-Emission-Tomography (PET) whole-body stage of prostate cancer [Seifert et al. European Urology 2023]. PSMA PET disease extent by PROMISE has been associated with relevant oncologic outcome, specifically overall survival in patients with various stages of prostate cancer.
Need:
Improved risk assessment across various stages of prostate cancer is urgently needed for guidance of clinical management and prospective study design.
Aim:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall survival
时间窗: up to 10 years
Time from PSMA-PET until death
次要结局
- Metastasis-free survival(up to 10 years)