PSMA-PET/CT for Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety of administration - change in temperature
研究概览
简要总结
Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker PSA (prostate specific antigen) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.
With some patients, the PSA-value is so low, that conventional nuclear medicine bone scanning or radiological CT or MRI cannot determine where the metastases are. Therefore, [18F]-Choline PET-CT was introduced to improve diagnostic imaging performance. However, in 30 to 40 percent of patients choline-PET does not localize tumor either, especially in small tumors and/or very low PSA values.
The PSMA PET is already routinely used in many European centres, and has shown a superior accuracy in these patients as compared to conventional imaging techniques. This has been a very consistent finding in scientifically reported patient studies.
Most of these investigations have been performed with PSMA labeled with Gallium-68. The investigators in Ghent, as others, have labeled PSMA with Fluor-18. This tracer provides many advantages, including a higher production yield enabling more patients to be scanned. Also from a perspective of radioprotection and financial costs, Fluor-18 is a better choice. Moreover, several recent studies, comparing Fluor with Gallium modalities seem to suggest equivalent or better diagnostic results, possibly because of a lower aspecific background activity.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after curative treatment (prostatectomy with or without lymphadenectomy or radiotherapy), or at primary diagnosis and staging.
排除标准
- •Age < 40 or > 70 years in phase-1; upper age limit is not applicable for the phase-2 trial.
- •Most patients will be > 65 years old, an estimate may be more than 80%.
- •Physically or mentally unfit to perform the sequential procedures
- •Refusal of patient to be informed about accidental findings on scans.
结局指标
主要结局
Safety of administration - change in temperature
时间窗: hourly checking of temperature from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Changes in temperature (expressed in °C)
Safety of administration - haemoglobin
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in haemoglobin concentration in plasma (expressed in g/dL)
Safety of administration - change in blood pressure
时间窗: hourly checking of blood pressure from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Changes in blood pressure (systolic and diastolic, expressed in mm Hg)
Safety of administration - follow up of adverse events
时间窗: Adverse events are followed up until 24 hours after PSMA administration.
Follow up of treatment-related adverse events according to CTCAE v4.0 criteria.
Safety of administration - thrombocytes
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in thrombocytes count in plasma (expressed in 10\^3/µL)
Safety of administration - ALT
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in ALT concentration in serum (expressed in U/L)
Safety of administration - change in heart rate
时间窗: hourly checking of heart rate from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Changes in heart rate (expressed in beats per min)
Safety of administration - leukocytes
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in leukocytes count in plasma (expressed in 10\^3/µL)
Safety of administration - Alkaline phosphatase
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in alkaline phosphatase concentration in serum (expressed in U/L)
Safety of administration - sodium
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in sodium concentration in serum(expressed in mmol/L)
Safety of administration - erythrocytes
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in erythrocytes count in plasma (expressed in 10\^6/µL)
Safety of administration - creatinine
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in creatinine concentration in serum (expressed in mg/dL)
Safety of administration - AST
时间窗: before and 300 minutes after 18F-PSMA administration
Changes in AST concentration in serum (expressed in U/L)
Biodistribution of 18F-PSMA
时间窗: 0 to 300 minutes after 18F-PSMA administration
Follow up of 18F-PSMA distribution over time in blood, urine, and organs. 18F-PSMA
次要结局
- Investigation of the stability of 18F-PSMA over time in plasma(0 to 300 minutes after 18F-PSMA administration)
- Establishment of critical organs(0 to 300 minutes after 18F-PSMA administration)