Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Microtubule Directed Chemo or AR-directed Therapy (NaFl PET/CT)
2019年11月14日 更新者：University of Wisconsin, Madison
NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either an Antimicrotubule Directed Agent or Androgen Receptor (AR)-Directed Therapies
The purpose of this research study is to evaluate a newer imaging technique, called 18F-Sodium Fluoride (NaF) positron emission tomography (PET).
NaF is a tracer (dye) that is very sensitive for changes in bone.
By using this tracer with positron emission tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved.
研究概览
地位
完全的
条件
详细说明
The study will look at how repeatable the NaF PET scans are before treatment.
Scans will also be performed after standard chemotherapy or hormone-directed treatment.
This will allow evaluation of how the NaF PET scans change with the chemotherapy or hormone-directed therapy.
In addition, NaF PET scans will be compared with standard computed tomography (CT) and bone scans, as well as prostate specific antigen (PSA).
This information could be used to develop better ways to measure prostate cancer bone lesions.
In turn, this could be used to better evaluate treatment effects of standard chemotherapy and other new drugs being developed to treat prostate cancer.
研究类型
观察性的
注册 (实际的)
58
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Bethesda、Maryland、美国、20892
- National Cancer Institute
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin Carbone Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
非概率样本
研究人群
Primary care clinic
描述
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Identifiable prostate cancer-related bone metastases on bone scan in the spine, pelvis or other bone
- Patients must be starting a microtubule directed chemotherapy regimen for metastatic castrate-resistant prostate cancer OR
- Patients must be starting a AR-directed regimen (e.g. Abiraterone, MDV-3100, TAK-700, etc) for treatment of metastatic castrate-resistant prostate
Exclusion Criteria:
- Concurrent treatment with any other agent that is being used with the expressed purpose of treating of prostate cancer outside of the planned treatment regimen
- Patients who have received radiotherapy less than 4 weeks prior to registration.
- Patients who have received prior Strontium-89, Samarium-153, or other radioisotope.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Cohort A: Microtubule directed chemotherapy treatment
Subjects receiving antimicrotubule chemotherapy-based treatment will have NaF PET/CT scans at baseline and again after 8 weeks of starting treatment.
A subset of subjects will have a second NaF PET/CT scan at baseline 1-8 days after the first baseline scan.
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Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B).
All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy.
A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 days of the initial scan to determine repeatability of NaF PET/CT scanning.
Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week).
Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).
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Cohort B: AR-directed therapy
Subjects receiving AR-directed therapy will undergo a baseline NaF PET/CT scan at baseline and again after having been on treatment for 6 weeks and again at 12 weeks.
A subset of subjects will also undergo a second baseline NaF PET/CT scan 1-8 days after the first baseline scan.
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Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B).
All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy.
A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 days of the initial scan to determine repeatability of NaF PET/CT scanning.
Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week).
Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.
大体时间：2 years
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NaF PET/CT scan will be performed within 14 days prior to starting chemotherapy (antimicrotubule directed chemotherapy) or hormone-directed therapy (baseline #1).
A portion of subjects (up to 20 subjects at each site, 60 subjects total) will have a second NaF PET/CT scan performed (baseline #2) within 1-8 days of the initial scan to see if measurements repeated over a short period of time are similar.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate changes on NaF PET/CT images in response to chemotherapy (antimicrotubule directed chemotherapy) or androgen receptor (AR)-directed therapy.
大体时间：2 years
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All subjects will undergo NaF PET/CT scanning at baseline and again either 8 weeks after starting treatment with antimicrotubule chemotherapy based treatment (Cohort A) OR at both 6 weeks and 12 weeks after starting AR-directed treatment (Cohort B).
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2 years
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Prostate Specific Antigen (PSA) response
大体时间：2 years
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Results from the NaF PET/CT scans will be compared with PSA and bone scan and CT scan results.
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2 years
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Response Evaluation Criteria in Solid Tumors (RECIST) response
大体时间：2 years
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2 years
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Radiographic progression free survival
大体时间：2 years
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2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Robert Jeraj, Ph.D.、University of Wisconsin, Madison
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年11月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2018年1月1日
研究注册日期
首次提交
2011年11月28日
首先提交符合 QC 标准的
2012年1月19日
首次发布 (估计)
2012年1月25日
研究记录更新
最后更新发布 (实际的)
2019年11月18日
上次提交的符合 QC 标准的更新
2019年11月14日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.