Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 14
- 主要终点
- Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression
研究概览
简要总结
The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed prostate cancer, that is either: newly diagnosed OR progressive as defined by standard PCWG3 criteria. note that metastatic disease is defined by either bone scintigraphy or by CT or MRI, or a combination of these tests, but not exclusively by molecular imaging criteria.
- •Patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, CT or MRI) demonstrates evidence of radiographic disease
- •Patient with progressive disease that is non-metastatic are eligible by biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart
- •Patients with progressive disease that is metastatic are eligible either by biochemical progression or radiographic progression or both
- •Patients are permitted to have had up to 2 months of prior hormonal therapy before entering this trial (and many therapeutic trials) and therefore, their progression criteria would apply to their pre-treatment imaging and PSA parameters Note: This criterion pertains to patients with newly diagnosed, untreated disease. This criterion does not apply to those who were already on therapy for metastatic CRPC.
- •Karnofsky performance status of >/= 50 (or ECOG/WHO equivalent)
- •Male (or transgender female) > 18 years of age
- •Patient must be able to understand and willing to sign a written informed consent document
- •Patient is anticipating starting a therapeutic strategy following imaging
排除标准
- •Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and non-invasive bladder cancer
- •Unable to lie flat, still or tolerate a PET scan
研究组 & 干预措施
Prostate cancer
Participants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol.
干预措施: PET/CT scan (Diagnostic Test)
Prostate cancer
Participants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol.
干预措施: 68Ga-HBED-iPSMA (Drug)
Prostate cancer
Participants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol.
干预措施: 18F-DCFPyL-iPSMA (Drug)
结局指标
主要结局
Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression
时间窗: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months
Measure predictive accuracy of the change in PSMA PET with respect to overall survival time.
时间窗: Time from the start of treatment to date of death from any cause, assessed up to up to 100 months
Measure predictive accuracy of the change in PSMA PET with respect to the time to metastasis
时间窗: Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months
次要结局
未报告次要终点