NCT06754085招募中3 期
A Phase III, Prospective, Open-Label, Single-Arm, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- The Positive Predictive Value of 18F-Florastamin PET/CT in patients with suspected recurrence of prostate cancer on a patient-level.
研究概览
简要总结
In this study, 18F-Florastamin PET/CT will be performed in patients with suspected recurrence of prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT 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
- Diagnostic
- 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
- •Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
- •Male ≥ 18 years of age.
- •Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
- •Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:
- •At least 6 weeks after radical prostatectomy (RP): PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL.; or
- •Post-radiation therapy, after radical radiotherapy (or cryoablation therapy): Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir .
- •Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;
- •ECOG score 0 or
- •Subjects who meet the following conditions in hematology, renal function, and liver function:
- •Platelet count>50 * 10^9/L Urea/urea nitrogen and creatinine<1.5 times upper limits of normal AST and ALT<2.5 times upper limits of normal.
- •Expected survival time ≥ 6 months.
- •Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.
排除标准
- •Subjects who have participated in other interventional clinical trials before signing ICF and were within the 5 half-lives of the investigational drug, or who are currently participating in other interventional clinical trials or have participated in clinical trials of radioactive drugs before signing ICF and have been discontinued for less than 3 months until the signing date of ICF.
- •Intravenous injection of iodinated contrast medium within 24 hours, or any high-density oral contrast medium (Such as barium sulfate. Oral water contrast is acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior to study drug administration.
- •Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.
- •If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration.
- •The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.
研究组 & 干预措施
18F-Florastamin Injection
Experimental
干预措施: Florastamin[18F] Injection (Drug)
结局指标
主要结局
The Positive Predictive Value of 18F-Florastamin PET/CT in patients with suspected recurrence of prostate cancer on a patient-level.
时间窗: 9 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate CancerProstate CancerNCT06011304HTA Co., Ltd.267
招募中
不适用
18F-FDHT PET/CT for re-staging patients with recurrent of prostate cancer after radiotherapy; a pilot studyprostate cancerNL-OMON43219niversitair Medisch Centrum Groningen20
进行中（未招募）
不适用
Phase III prospective clinical trial: 18F-FCH/PET evaluation in early diagnosis of disease recurrence in prostate cancer - FCH_PETEUCTR2009-011189-27-ITISTITUTI FISIOTERAPICI OSPITALIERI
招募中
3 期
18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid AdenomasHyperparathyroidism, PrimaryNCT04895631Thomas Hope140
Unknown
不适用
Clinical Application of 18F-PEG3-FPN PET Imaging in Diagnosis and Staging of Malignant MelanomaMelanomaNCT04747561Wuhan Union Hospital, China50