A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Laser Focal Therapy of Intermediate Risk Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Detection of Metastases
研究概览
简要总结
To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal therapy cohort.
详细描述
DESCRIPTION OF DRUG
Mechanism of action:
Fluciclovine F 18 is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters, such as LAT-1 and ASCT2, which are upregulated in prostate cancer cells. Fluciclovine F 18 is taken up to a greater extent in prostate cancer cells compared with surrounding normal tissues.
Pharmacodynamics:
Following intravenous administration, the tumor-to-normal tissue contrast is highest between 4 and 10 minutes after injection, with a 61% reduction in mean tumor uptake at 90 minutes after injection.
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
盲法说明
No masking
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 45 years of age or older.
- •Diagnosis of prostate adenocarcinoma.
- •Clinical stage T1a, T1b, T1c, T2a, T2b orT2c.
- •Gleason score of 7 (3+4 or 4+3).
- •PSA density less than 0.
- •One, two, or three tumor suspicious regions identified on multiparametric MRI.
- •Negative radiographic indication of extra-capsular extent.
- •Karnofsky performance status of at least
- •Estimated survival of 5 years or greater, as determined by treating physician.
- •Tolerance for anesthesia/sedation.
- •Ability to give informed consent.
排除标准
- •Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- •Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. ( (http://www.urospec.com/uro/Forms/ipss.pdf)
- •History of other Primary non-skin malignancy within previous three years.
研究组 & 干预措施
Men with Gleason Score 7 prostate cancer
Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy.
干预措施: Axumin PET/CT (Drug)
结局指标
主要结局
Detection of Metastases
时间窗: One day
Number of patients with detection of metastasis Secondary Outcome Measure Description: Number of patients with local uptake of Axumin
次要结局
未报告次要终点