2023-504026-19-01招募中3 期
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
Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH18 个研究点 分布在 5 个国家目标入组 330 人开始时间: 2024年1月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 18
- 主要终点
- Confidential commercial information
研究概览
简要总结
To assess, in an independent assessment by 3 readers blinded to the clinical data, the sensitivity and specificity of [18F]PSMA-1007 positron-emission, computer-aided tomography (PET-CT) in detecting pelvic nodal metastases (N1) in newly diagnosed high-risk and very-high-risk prostate cancer (region-based patient-level analysis, at least one hemi-pelvis is correctly diagnosed), using histology as the standard of reference.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient (male) is aged 18 years or above
- •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
- •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
- •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, OR Clinical category T3a or greater, –OR Serum PSA level greater than 20 ng/ml.
- •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
- •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
- •The patient is clinically unstable or requires emergency treatment
- •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
- •The patient has received any therapy – be it radiation, surgical or drug therapy – for his prostate cancer
- •The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of [18F]PSMA-1007
- •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)
- •The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator
- •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
- •The patient has previously been enrolled in this trial
- •Confidential commercial information
- •The patient has histological evidence of small-cell carcinoma of the prostate
结局指标
主要结局
Confidential commercial information
Confidential commercial information
次要结局
未报告次要终点
研究者
Director Medicinal Chemistry
Scientific
Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
研究点 (18)
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