Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Primary objective: To confirm the PPV of the new tracer (patient-based PPV)
研究概览
简要总结
Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.
详细描述
In this prospective, single-armed diagnostic imaging study men undergoing standard-of-care PSMA PET/CT using [18F]PSMA-1007 shall be studied. The primary objective is to confirm the positive predictive value (PPV) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. Secondary outcomes shall include patient based rate of pathological-scans stratified by PSA, the PPV stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
- •Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:
- •Post prostatectomy: two consecutive PSA > 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL > post-therapy nadir (ASTRO consensus definition)
- •Male patients >18 years old
- •PSA measured ± 4 weeks of the PSMA-PET/CT
- •Patients willing and able to consent to the informed consent document
排除标准
- •Patients with ADT within 6 months prior to the PSMA-PET/CT
- •Inability to provide informed, written consent
- •Patients undergoing active treatment for a second non-prostatic malignancy
结局指标
主要结局
Primary objective: To confirm the PPV of the new tracer (patient-based PPV)
时间窗: At one year follow up
The primary end point is the per patient PPV for the detection of PSMA-positive tumour lesions as confirmed by either a) histology or b) a composite reference standard of imaging and/or PSA fall following focal therapy in the absence of systemic therapy.
次要结局
- • To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer(Within one week of scan)
- To explore the regional based PPV(At one year follow up)