The Prognostic Value of AI-based Measurements of Tumour Burden in PSMA PET-CT in Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Tumour burden (cm3) in relation to overall survival
研究概览
简要总结
The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence).
详细描述
In Sweden, prostate cancer is diagnosed in 10,000 men annually and the mortality rate of 2,400 is among the highest worldwide. Some prostate cancers are at high risk of metastatic progression to lethal disease and require correct staging or detection of recurrence and multidisciplinary treatments.
The investigators have developed an AI-based method to detect and quantify tumours and metastases in 18F-PSMA-1007 PET-CT scans in patients with prostate cancer. The method can find tumours in the prostate and metastases in pelvic lymph nodes, distant lymph nodes and in bone, both in patients referred to the PET-CT scan for primary staging of high-risk prostate cancer for secondary staging due to recurrence.
Patients referred to clinically indicated PSMA PET-CT due to either initial staging of primary high-risk prostate cancer or due to biochemical recurrence will be eligible for inclusion. The AI-based method will automatically calculate TV, TU and number of suspected lesions and this information will be stored in a database. The values will after a 5 year follow-up period be analysed with regard to overall survival (OS) and progression-free survival (PFS).
The primary aim of the present study is to evaluate how tumour burden, measured as TV and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence). A secondary aim is to evaluate how the AI-derived measurements predict time to biochemical recurrence in a sub-cohort of patients with newly diagnosed high-risk prostate cancer. Tertiary aims are to evaluate the difference in TV and TU measured with two different segmentation methods (a threshold of 50% of SUVmax in each lesion and a threshold of SUV 4) in relation to OS and biochemical PFS. The impact of the number of automatically calculated suspected lesions will also be investigated regarding OS and biochemical PFS as well as to the difference in tumour burden measured with AI and manually.
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
- 20 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients referred to a clinically indicated 18F-PSMA-1007 PET-CT scan at Skåne University Hospital, Lund or Malmö, Sweden
排除标准
- •Patients under 20 years old
研究组 & 干预措施
Patients with prostate cancer
Patients referred to clinically indicated PSMA PET-CT due to initial or secondary staging of prostate cancer
干预措施: AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans (Device)
结局指标
主要结局
Tumour burden (cm3) in relation to overall survival
时间窗: 5-year follow-up
Evaluate how the total tumour burden (cm3) predicts overall survival (OS). The total tumour burden will automatically be calculated by the AI-based method and will through Cox regression analysis be related to OS
次要结局
- Comparing total tumour burden (cm3) measured manually and by the AI-based mehtod(5 years)
- Comparing two different segmentation methods in relation to OS(5 years)
- Tumour burden (cm3) in relation to biochemical recurrence(5 years)
- Number of tumours/metastases in relation to OS(5 years)
研究者
Elin Tragardh
Professor
Skane University Hospital