Evaluation of [18F] Fluorocholine PET/CT for Detection of Regional Lymph Node Metastases From Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- The primary target variable "metastasizes to regional lymph nodes" (yes/no) will be used to estimate the diagnostic usefulness of FCH PET/CT in terms of sensitivity, specificity, positive and negative predictive values.
研究概览
简要总结
The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of regional lymph node metastases from prostate cancer. In addition, the investigators want to evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate cancer.
详细描述
The purpose of this prospective trail is to improve the staging of patients with prostate cancer. The investigators focus on the group of patients with a newly diagnosed prostate cancer, and specifically the ones who have an intermediate and high risk of disseminated prostate cancer.
The aim is to improve staging by replacing the traditional invasive method, the lymphadenectomy, which has a rather low sensitivity by a non-invasive method, 18F-choline PET/CT which has a presumably superior sensitivity.
The treatment of patients with prostate cancer relies on the stage of the disease. Patients with disseminated prostate cancer are incurable and are treated with palliatively. In contrast, patients with localized prostate cancer are offered curative therapy. Hence, the stage of prostate cancer is crucial for the choice of treatment.
The potential benefits are
- The patients avoid the surgical trauma including complications and convalescents period.
- The accuracy of the prostate cancer staging is improved, the potential of which is better survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with a biopsy confirmed prostate cancer who awaits curative treatment and have
- •An elevated level of prostate-specific antigen PSA>10 ng/mL (nanogram per milliliter) or/and
- •A Gleason score > 6 or/and
- •A TNM staging of T3
排除标准
- •Patients who withdraw their informed consent.
- •Patients who have a bone scan indicates metastatic prostate cancer.
- •Patients who have a TNM stage is T4
- •In the case we detect a patient having an obvious other major illness e.g. lung cancer, the patient is referred to relevant treatment. Depending on the illness the might be excluded from the study.
结局指标
主要结局
The primary target variable "metastasizes to regional lymph nodes" (yes/no) will be used to estimate the diagnostic usefulness of FCH PET/CT in terms of sensitivity, specificity, positive and negative predictive values.
时间窗: The [18F] Fluorocholin PET/CT and the lymphadenectomi is done within 1 month
次要结局
未报告次要终点