Evaluation of the Metastasis and Recurrence of Prostate Cancer With 18F-PSMA PET/CT
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 18F-PSMA PET/CT imaging
研究概览
简要总结
This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.
详细描述
This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.And make some comparison with those 3 methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with initial diagnosis of prostate cancer; 1）T2 stage: PSA>20ng/ml, Gleason Score >= 8; 2）T3 or T4 stage; 3）The imaging examination was negative or localized metastasis of the pelvic lymph node, but there was no distant metastasis of lymph nodes or bone and internal organs other than the pelvic cavity.
- •Patients with biochemical recurrent prostate cancer; 1）After the RRP surgery, the serum PSA was over 0.2 ng/ml in two consecutive sera; 2）After the radiotherapy: the lowest PSA is up to 2 ng/ml.
- •Patients with CRPC. 1）The serum testosterone is in the castration level (< 50 ng/dL or < 1.7 nmol/L); 2）The PSA is elevated 3 times in a row, the base value is increased by more than 50%, and the PSA > 2ng/mL(the interval is one week); 3）The continuation of the anti-androgen drugs, flunamine was stopped for at least 4 weeks, and biglumide was suspended for at least 6 weeks; 4）Despite the continued standard androgen deprivation therapy, the PSA is still progressing.
排除标准
- •Patients who are unwilling to participate in the study or unwilling to sign the informed consent forms;
- •Patients who are critically ill, suffering from mental illness and cannot cooperate with the examination;
- •There are electronic implants, such as pacemakers and insulin pumps in the body, and magnetic metal foreign objects in the spot.
结局指标
主要结局
18F-PSMA PET/CT imaging
时间窗: 4 hours
The outcome of 18F-PSMA PET/CT imaging.
次要结局
- MRI imaging(4 hours)
- Bone scan imaging(6 hours)