jRCT2032240674招募中不适用
Prospective, Multi-Center Study to Assess the Diagnostic Performance of 18F-PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer (18F-PSMA-1007 PET/CT in prostate cancer)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 主要终点
- pelvic lymph node metastasis
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •(1) The patient (male) is aged 18 years or above.
- •(2) The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate.
- •(3) The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment.
- •(4) The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following:
- •Overall ISUP grade group 4 or 5,
- •Clinical category T3a or greater,
- •Serum PSA level greater than 20 ng/ml.
- •(5)The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure.
排除标准
- •(1) Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection.
- •(2) The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.
- •(3) The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of [18F]PSMA-
- •(4) The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan).
- •(5) The patient is closely affiliated to the investigation site; e.g., is a first-degree relative of the investigator.
- •(6) At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit.
- •(7) Patients who were enrolled in this clinical trial but withdrew for some reason.
- •(8) The patient has previously undergone PET imaging with any PSMA-avid product.
- •(9) The patient has histological evidence of small-cell carcinoma of the prostate.
- •(10) The patient is clinically unstable or requires emergency treatment.
- •(11) The patient is part of a vulnerable population, e.g., but not limited to the patient is incapacitated in such a way that renders him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient.
结局指标
主要结局
pelvic lymph node metastasis
The determination of pelvic lymph node metastasis by histopathology results is considered SOT.
diagnostic performance of 18F-PSMA-1007 PET/CT
The diagnostic performance (sensitivity, specificity) of 18F-PSMA-1007 PET/CT is evaluated on a site-based patient basis (accurate diagnosis of at least hemi-pelvis).
次要结局
- Diagnostic performance of 18F-PSMA-1007 PET/CT (patient-by-patient)
- Diagnostic performance of 18F-PSMA-1007 PET/CT (region basis)
- Diagnostic performance comparison with conventional imaging
- Diagnostic performance of 18F-PSMA-1007 PET/CT (PPV and NPV)
- Intra- and inter-reader agreement
研究者
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