The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa.
研究概览
简要总结
This study aims to investigate the diagnostic value of FAPI PET/CT, relative to standard-of-care imaging using PSMA PET/CT, in staging of newly diagnosed PCa. FAPI PET/CT will be visually and quantitatively correlated to PSMA PET/CT resulting in detection rates and target-to-background ratios. If available, histopathology of resected specimens will serve as reference test for operated patients in order to determine diagnostic accuracy. All outcomes are descriptive and serve as pilot for a potential subsequent larger prospective diagnostic study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
All scans will be reviewed by two senior nuclear medicine physicians (NWZ-Alkmaar and/or NCI-AVL), separately and blinded to any clinical information. If a consensus is not reached, a third observer is included.
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
- •Male, aged ≥ 18 years;
- •WHO performance status 0, 1 or 2;
- •Written informed consent;
- •Biopsy-proven newly diagnosed PCa;
- •International Society of Urological Pathology (ISUP) grade group (GG) ≥ 3 and/or PSA ≥ 20 ng/ml and/or ≥cT3a.
- •If all of the criteria above are met, a subject must also meet all of the following subgroup specific criteria:
- •Group 1 (n=15):
- •PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or distant metastases.
- •Group 2 (n=15):
- •PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or distant metastases;
- •Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti ≥40%) [22];
- •Scheduled for (laparoscopic) prostatectomy including ePLND.
排除标准
- •Known second malignant disease that may complicate image interpretation.
- •Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions.
研究组 & 干预措施
FAPI PET/CT
Patients will undergo an additional diagnostic FAPI PET/CT scan within four weeks after PSMA PET/CT and within four weeks before planned treatment.
干预措施: FAPI PET/CT (Diagnostic Test)
结局指标
主要结局
detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa.
时间窗: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
次要结局
- Diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging of newly diagnosed PCa(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)
- Correlate histopathological findings after robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND) to FAPI PET/CT findings to determine its diagnostic accuracy for staging of newly diagnosed PCa.(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)
- Correlate laboratory parameters (prostate specific antigen (PSA) levels) after treatment to FAPI PET/CT findings to determine its diagnostic accuracy.(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)
- Obtain preliminary data on the FAP overexpression in primary prostate tumor and lymph node metastases by immunohistochemical staining.(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)
- Correlate immunohistochemical staining with FAPI uptake measured on PET/CT(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)