PSMA PET Imaging of Recurrent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,171
- 试验地点
- 13
- 主要终点
- Disease localization by PSMA PET/MR
研究概览
简要总结
The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven adenocarcinoma of the prostate
- •Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)
- •For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy:
- •PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients
- •Note: The most recent PSA value must be within 6 weeks of consent
- •For patients who have received additional treatment in the recurrent or metastatic setting:
- •° PSA ≥ 2 ng/ml above the most recent therapy nadir
- •Age ≥ 18 years
- •Patient must be able to tolerate PET/CT or PET/MR imaging
排除标准
- •Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.
研究组 & 干预措施
Ga-HBED-iPSMA PET with CT or MRI
Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
干预措施: Ga-HBED-iPSMA PET (Drug)
Ga-HBED-iPSMA PET with CT or MRI
Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
干预措施: PET/CT (Diagnostic Test)
Ga-HBED-iPSMA PET with CT or MRI
Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
干预措施: MRI (Diagnostic Test)
Ga-HBED-iPSMA PET with MRI
Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.
干预措施: Ga-HBED-iPSMA PET (Drug)
Ga-HBED-iPSMA PET with MRI
Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Disease localization by PSMA PET/MR
时间窗: 2 years
次要结局
- PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT(2 years)
- Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)(2 years)