18F-Fluciclovine PET CT as an Indicator of Therapeutic Response in Metastatic Prostate Carcinoma (M1PCa)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV)"
研究概览
简要总结
This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate metabolic response by fluciclovine F18 (18F-fluciclovine) PET qualitatively and semi-quantitatively with standardized uptake values (SUV) following androgen deprivation therapy (ADT) plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and prostate-specific antigen (PSA) response.
SECONDARY OBJECTIVES:
I. To correlate pelvic 18F-fluciclovine PET imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection to determine 18F-fluciclovine PET imaging sensitivity and specificity for pelvic lymph node cancer involvement.
II. To evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival (defined by Prostate Cancer Working Group 2 [PCWG2] criteria).
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
- •Histologically or cytologically proven prostate carcinoma
- •Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI)
- •Castration naive disease, no prior systemic therapy for prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •Ability to understand and willingness to sign informed consent
排除标准
- •Known brain metastasis
- •Small cell carcinoma of the prostate
研究组 & 干预措施
Diagnostic (fluciclovine F18, PET-CT)
Within 4 weeks before starting SST, patients receive fluciclovine F18 IV then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.
干预措施: Computed Tomography (Procedure)
Diagnostic (fluciclovine F18, PET-CT)
Within 4 weeks before starting SST, patients receive fluciclovine F18 IV then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.
干预措施: Fluciclovine F18 (Drug)
Diagnostic (fluciclovine F18, PET-CT)
Within 4 weeks before starting SST, patients receive fluciclovine F18 IV then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV)"
时间窗: Up to 2 years
Will evaluate metabolic response by 18F-fluciclovine PET qualitatively and semi-quantitatively with SUV and correlate the findings with size changes as defined by conventional imaging prostate specific antigen (PSA) response. The percentage of change in the 18F-fluciclovine maximum standardized uptake value (SUVmax) after therapy will be calculated as follows (\[pretreatment corrected SUVmax - posttreatment corrected SUVmax\]/pretreatment corrected SUVmax) x 100. Similar calculations will be performed for mean SUV, metabolic tumor volume, and total volume activity. An analysis of the quantitative data was recently performed for the 2 participants.
次要结局
- 18F-fluciclovine PET Imaging Response - SUVMax(Up to 2 years)
- 18F-fluciclovine PET Imaging Response - SUVMean(Up to 2 years)
- 18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume(Up to 2 years)
- Sites of Progressive Disease Development(Up to 2 years)
- Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR)(Up to 2 years)