PET Imaging as a Biomarker of Systemic Treatment Response for Men With Metastatic Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Changes in prostate cancer metastases as measured by 11C-acetate and 18F-fluoride PET in response to systemic therapy
研究概览
简要总结
This clinical trial studies carbon-11 acetate and fluorine F 18 sodium fluoride positron emission tomography (PET) as a biomarker of treatment response in patients with prostate cancer that does not respond to treatment with hormones and has spread to other parts of the body. Carbon-11 acetate and fluorine F 18 sodium fluoride are radioactive drugs that may be useful in evaluating prostate cancer activity in response to treatment. Comparing results of diagnostic procedures such as carbon-11 acetate and fluorine F 18 sodium fluoride PET done before and after therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
详细描述
PRIMARY OBJECTIVES:
I. Demonstrate that carbon-11 acetate (11C-acetate) and 18F-fluoride (fluorine F 18 sodium fluoride) PET scans change as a result of treatment for men with metastatic castration-resistant prostate cancer by comparison of pre-treatment and 6-12 week post-treatment images (standardized uptake value [SUV], influx constant [Ki], and rate constant [K1]) with clinical response measures.
SECONDARY OBJECTIVES:
I. Compare results from 11C-acetate and 18F-fluoride PET scanning with the patient's clinical bone scan and determine which predicts clinical response better.
II. Compare changes in 11C-acetate and 18F-fluoride PET with changes in prostate-specific antigen (PSA) level.
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 preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
- •At the time of enrollment, patients must demonstrate evidence of castration-resistant prostate cancer with a documented castrate level of serum total testosterone (< 50 ng/dL) while on continuous androgen deprivation therapy
- •Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
- •Be willing and able to comply with scheduled visits and other trial procedures
- •Presence of at least one measurable or detectable metastasis as defined by bone scintigraphy, computed tomography (CT) scan appearance (magnetic resonance imaging [MRI] if indicated), or plain x-ray appearance
排除标准
- •Any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
- •A serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
- •Expected lifespan of 12 weeks or less
- •Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
- •Radiation treatment to bone less than 4 weeks from the first PET scan
- •Radiopharmaceutical treatment to bone less than 4 weeks from first PET scan
- •Treatment with granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte (G-CSF) within 4 weeks prior to first PET scan; patients should avoid treatment with these agents between the baseline and 6-12 treatment week imaging sessions
- •Inability to lie still for imaging
- •Weight > 300 pounds (lbs)
结局指标
主要结局
Changes in prostate cancer metastases as measured by 11C-acetate and 18F-fluoride PET in response to systemic therapy
时间窗: Baseline to up to 12 weeks
Percentage change between pre-treatment and post-therapy measurements will be computed for PET measures. Log transformations will be considered if the rates of change are highly skewed. Additionally, changes in PET measures will be analyzed descriptively by a stem-and-leaf plot.
次要结局
- Change in urinary N-telopeptide(Baseline to up to 30 days post-PET)
- Clinical response data (response, stable disease or progression)(Up to 5 years)
- Change in PSA parameters(Baseline to up to 30 days post-PET)
- Proportion of both 11C-acetate and 18F-fluoride PET scans and 99mTc bone scans in discovering suspicious sites that are later confirmed by standard bone scans(Up to 5 years)
- Change in bone alkaline phosphatase(Baseline to up to 30 days post-PET)
- Progression-free survival (PFS) using PCWG2(Up to 5 years)
- SRE defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia(Up to 5 years)