Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Tumor T-staging
研究概览
简要总结
This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).
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
- •Patients or their legal medical decision makers will sign an informed consent prior to entering the study.
- •Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer.
- •Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)
排除标准
- •Unable to obtain consent
- •Weight >250 kg (weight limitation of scanners)
- •Unable to lie flat for 30 minutes to complete the PET or MRI imaging
- •Severe claustrophobia precluding image acquisition
- •Lack of intravenous access
- •Non-MRI compatible pacemaker or hardware
- •eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast
- •Prior androgen deprivation therapy
结局指标
主要结局
Tumor T-staging
时间窗: Through study completion, this is expected to be reviewed within 1 year of imaging
Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)
次要结局
- Sensitivity of PSMA-1007 PET(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Sensitivity of MRI(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Metastatic Staging(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Negative Predictive Value of PSMA-1007 PET(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Specificity of MRI(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Positive Predictive Value of PSMA-1007 PET(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Nodal Staging(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Longest Tumor diameter(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Identification of non-dominant lesion(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Specificity of PSMA-1007 PET(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Negative Predictive Value of MRI(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Positive Predictive Value of MRI(Through study completion, this is expected to be reviewed within 1 year of imaging)
- Identification of dominant lesion(Through study completion, this is expected to be reviewed within 1 year of imaging)