[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer or Salivary Gland Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI.
研究概览
简要总结
This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see whether these scans may be better able to find places in the body where your prostate cancer may have spread.
详细描述
Our preliminary studies have shown that whole body FDG-PET imaging identifies areas of abnormal metabolism in a majority of tumor sites in patients with progressive disease and that changes in FDG accumulation parallel changes in PSA after treatment. This suggests that changes in FDG metabolism may provide an early assessment of treatment outcomes. In previous work we established a methodology to examine a radiotracer in patients with progressive disease and abnormal imaging studies, which we have applied to the clinical states of non-castrate and castrate metastatic disease. This design is characterized by:
1) Evaluation of uptake on a site-by-site basis in relation to conventional studies 2) Standardization of uptake values in tumor relative to a normal organ 3) Controlling for progression using standard measures of progression including a rising PSA, new or enlarging lesions on bone or transaxial imaging, and new symptoms of disease. In the present study we are evaluating fluorinated dihydrotestosterone (FDHT) in addition to FDG. FDHT is targeted to the AR and has been shown in preliminary studies to visualize prostate cancers in man. This study will apply our established methods to investigate FDHT imaging in patients with progressive prostate cancer. In the selected cases where tumor is available, we will study associations between FDHT accumulation and AR expression.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed prostate cancer.
- •Progressive disease manifest by either:
- •Imaging modalities:
- •Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease. Or
- •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.
- •Visible lesions by either CT, bone imaging, or MRI consistent with disease.
- •Informed consent.
排除标准
- •Previous anaphylactic reaction to either FDHT or FDG
- •Hepatic: Bilirubin > 1.5 x upper limit of normal (ULN), AST/ALT >2.5 x ULN, albumin < 2 g/dl, and GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN
- •Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min
- •Salivary Gland Cancers
- •Inclusion Criteria:
- •Histologically proven diagnosis of salivary cancer with AR expression detected by immunohistochemistry
- •Measurable disease as defined by RECIST v1.1 criteria
- •Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
- •Age ≥ 18 years
- •ECOG performance status 0 or 1
- •AST/ALT < 3xULN
- •No prior AR-targeted therapy (Exception: AR-targeted therapy administered in the adjuvant setting and with disease recurrence more than 6 months since treatment completion)
- •Exclusion Criteria:
- •Uncontrolled or untreated brain metastases
- •Class 3 or 4 congestive heart failure
- •Uncontrolled hypertension (systolic BP >170 mmHg or diastolic BP >105 mmHg at screening)
- •Vascular or ischemic event within 6 months of study registration.
研究组 & 干预措施
1
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
干预措施: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone (Drug)
结局指标
主要结局
To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI.
时间窗: Baseline, 4 weeks and 12 weeks
次要结局
- The kinetics, metabolism, and biodistribution will be assessed.(Baseline. 4 weeks and 12 weeks)
- relationship between FDHT uptake and tumor diffusivity(2 years)
- To correlate the accumulation of 18FDHT to 18FDG.(2 years)
- To study changes in 18FDHT accumulation over time in patients treated with: Castration and other hormones, Chemotherapy, Agents directed toward the androgen receptor(2 years)
- relationship between FDHT uptake and tissue analyses(2 years)