Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Physician responses to a questionnaire
研究概览
简要总结
In this study we aim to more precisely define the clinical utility of PSMA imaging across a range of clinical indications in men with prostate cancer. To accomplish this, we will make the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation oncologists at Johns Hopkins and survey physicians as to the indication for ordering the PET/CT and if a change in management occurred as the result of new information gained from the scan. We believe these data will prove critical for planning future studies aimed at evaluating the efficacy of this test for improving patient outcomes.
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Willingness to signed informed consent
- •Histologically confirmed adenocarcinoma of the prostate
- •PSA measurement ≤60 days prior to study enrollment
- •Completed radiographic evaluation with whole-body bone scan (99mTc-MDP or Na18F) and cross-sectional imaging (CT or MRI) of the abdomen and pelvis ≤60 days prior to study enrollment
排除标准
- •Administered a radioisotope within 5 physical half-lives prior to study enrollment
- •History of other malignancy diagnosed within the last 5 years (exceptions: low grade urothelial carcinoma of the bladder, squamous cell carcinoma or basal cell carcinoma of the skin).
研究组 & 干预措施
adenocarcinoma of the prostate
干预措施: 18F DCFPyL- Radiopharmaceutica (Drug)
结局指标
主要结局
Physician responses to a questionnaire
时间窗: less than 1 year
The Post-PET/CT questionnaire will determine if the PET/CT scan results in changes to clinical management of patient illness.
次要结局
未报告次要终点