Investigation of the Sensitivity and Specificity of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of 68Ga-PSMA-11 PET/CT compared to that of CT alone and bone scan in two different cohorts of prostrate cancer patients.
研究概览
简要总结
This is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer.
Participants will receive regular standard of clinical care. The only study-specific procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission tomography/computed tomography) scan. Participants will be followed for two hours after the infusion for identification of any immediate adverse events (AE), and will be contacted by telephone after 7 to 14 days to enquire about any delayed AEs.
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. The standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the PET/CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 or older
- •Previously diagnosed with prostate cancer, under referring physician's care
- •ECOG performance status 0 - 3, inclusive
- •Able to understand and provide written informed consent
- •Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection
排除标准
- •Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- •Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
- •Patients with unmanageable claustrophobia
研究组 & 干预措施
Biochemical Reoccurrence
Patients with biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or patients with biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC) and compare it to bone scan and CT in 2 groups:
PSA >= 0.2 ng/mL and <= 0.5 ng/mL or PSA > 0.5 ng/ml
干预措施: 68Ga-PSMA PET/CT (Drug)
High Risk Prostate Cancer
Patients with high risk prostate cancer who have not received any definitive treatment. These high-risk patients are defined using the D'Amico Classification System: Those with a PSA of more than 20, or a Gleason score equal to or greater than 8, or have a clinical stage greater than T2c.
干预措施: 68Ga-PSMA PET/CT (Drug)
结局指标
主要结局
Sensitivity and specificity of 68Ga-PSMA-11 PET/CT compared to that of CT alone and bone scan in two different cohorts of prostrate cancer patients.
时间窗: 6 months
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. A target lesion list will be created, finalized and entered into the research study file. Reviewer will assign each patient an overall likelihood of prostate cancer score, equal to the highest score of any target lesion on the PET/CT scan. Following the entry of final PET/CT, CT-only and bone scan target lesion lists and overall likelihood scores into the study file, all the experienced readers will become un-blinded and adjudicate by consensus in conjunction with referring physicians all lesions identified by each on their respective datasets and will assign a final consensus to each lesion. Each target lesion identified by each reader will be followed clinically, radiologically and histopathologically over a minimum period of 6 months and the final consensus can be modified based on this follow-up.
次要结局
- The secondary endpoint is the number of adverse events, both immediate and delayed.(baseline (i.e. Imaging visit) and at the end of study visit (day 7 to day 14))
研究者
Rajan Rakheja
Assistant Professor
University of Saskatchewan