A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men With Castration-Resistant Prostate Cancer and Bone Metastases (BMS #180-279)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Changes in 18F-fluoride PET (SUV) - Tumor Bone
研究概览
简要总结
This phase II trial is studying how well fluorine F 18 sodium fluoride positron emission tomography (PET) works in evaluating response to dasatinib in patients with prostate cancer and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride PET, may help doctors predict a patient's response to treatment and help plan the best treatment.
详细描述
PRIMARY OBJECTIVES:
I. Determine if changes in regional fluoride incorporation, measured by 18F-fluoride PET (SUV and Ki), occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.
SECONDARY OBJECTIVES:
I. Determine if changes in 18F-fluoride transport (K1), an indicator of blood flow, and therefore, an indirect marker of angiogenesis, occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.
OUTLINE: This is a multicenter study.
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
- •Must be able to provide a written informed consent
- •Men 18 years or older with metastatic castration-resistant prostate cancer enrolling onto the Febbo clinical trial with dasatinib therapy (must meet all inclusion criteria for dasatinib treatment study and comply with requirements of that specific clinical trial)
- •Histologic confirmation of original prostate cancer diagnosis
- •Presence of at least one convincing bone metastasis as defined by bone scintigraphy, computed tomography (CT) scan (magnetic resonance imaging [MRI] if indicated), or plain X-ray
- •Must currently have castrate testosterone levels (< 50 ng/dL) from orchiectomy or maintenance on a luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist
排除标准
- •On the nilutamide-only arm (Arm A of the clinical therapeutic trial)
- •Note: However, if a patient crosses-over from nilutamide at the time of progression to add dasatinib therapy, he may be eligible for 18F-fluoride PET imaging protocol if he meets all inclusion criteria for this trial
- •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
- •Initiation of bisphosphonate therapy less than 4 weeks from the first PET scan
- •Radiation treatment to bone less than 4 weeks from 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 CSF (G-CSF) within 4 weeks prior to first PET scan
- •Inability to lie still for the imaging
- •Weight > 300 lbs. (due to equipment specifications)
结局指标
主要结局
Changes in 18F-fluoride PET (SUV) - Tumor Bone
时间窗: Baseline and 12 weeks
Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax
Changes in 18F-fluoride PET SUV - Normal Bone
时间窗: Baseline and 12 weeks
Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax
Changes in 18F-fluoride Ki - Normal Bone
时间窗: Baseline and 12 weeks
Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone
Changes in 18F-fluoride Ki - Tumor Bone
时间窗: Baseline and 12 weeks
Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone
次要结局
- Changes in 18F-fluoride Transport (by Patlak Flux) - Normal(Baseline and 12 weeks)
- Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor(Baseline and 12 weeks)