Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The rate of patients presenting at least one (i.e >0) CTC-PSMA positive.
研究概览
简要总结
This is a prospective, monocentric, proof of concept study aims to identify in prostate cancer patients, a potential relationship between CTC-PSMA positivity and 18F-PET-PSMA results as well as patient outcome.
Patients with 18F-PET-PSMA indication will perform imaging extension work-up as part of current practice. If they agree to participate in the study, a blood sample will be performed prior to the 18F-PET-PSMA standard imaging (T1).
In order to evaluate the potential relationship between CTC-PSMA and 18F-PET-PSMA imaging, the study will be presented to all patients seen in consultation for an extension workup for prostate cancer. This will allow to analyze the results in patients with different level of tumor burden afterward to define the following three groups based on imaging results:
Group 1 : no tumor volume Negative 18F-PET-PSMA (patients without uptake lesion)
Group 2 : low or medium tumor volume Positive 18F-PET-PSMA (patients with an uptake in prostate bed or with an oligo-metastatic extension (number of lesions < 6))
Group 3 : high tumor volume Positive 18F-PET-PSMA (patients with a polymetastastatic extension (number of lesions ≥ 6)).
In each of these groups, the rate of patients with positive PSMA CTC will be analyzed (i.e. patient having at least one CTC-PSMA positive).
For patients with an indication of treatment by 177LuPSMA-617 (PLUVICTO®) according to standard practices, additional blood samples will also be collected at the following time points: 2nd cycle (T2) and 4th cycle of treatment (T3), just before injection. For these patients, data will be collected up to 6 months after the last treatment injection (clinical and biological data; results of tumor assessments based on 18F-PET-PSMA imaging).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age ≥ 18 years
- •Histologically confirmed adenocarcinoma of the prostate
- •Indication for 18F-PET-PSMA imaging
- •Signed written informed consent
- •Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- •Patient affiliated to a Social Health Insurance in France.
排除标准
- •Patients with a contraindication to 18F-PET-PSMA
- •Patient with an established neuro endocrine prostate cancer
- •Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors)
- •Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- •Patient who has forfeited his freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
研究组 & 干预措施
Patients with prostate cancer
干预措施: Patients with 18F-PET-PSMA indication (Other)
结局指标
主要结局
The rate of patients presenting at least one (i.e >0) CTC-PSMA positive.
时间窗: 1 day for each patient
The rate of patients presenting at least one CTC-PSMA positive is defined as the ratio of the number of patients having at least one CTC-PSMA positive divided by the total number of patients evaluable in each group (G1, G2, G3).
次要结局
- CTC-PSMA change will be defined as the number of CTC-PSMA positive at C2/C4 minus the number of CTC-PSMA positive at inclusion, if feasible.(18 weeks for each patient)
- The total number of CTC will be evaluated.(18 weeks for each patient)
- The number of CTC-PSMA positive will be evaluated at inclusion for each group and just before the 2nd and 4th course of 177LuPSMA (C2/C4).(18 weeks for each patient)
- CTC-PSMA change will be defined as the number of CTC-PSMA positive at C2/C4 minus the number of CTC-PSMA positive at inclusion, if feasible.(18 weeks for each patient)
- The total number of CTC will be evaluated.(18 weeks for each patient)
- The response to 177LuPSMA(15 months)
- The number of CTC-PSMA positive will be evaluated at inclusion for each group and just before the 2nd and 4th course of 177LuPSMA (C2/C4).(18 weeks for each patient)