Clinical trial NCT03111914: Applications of Dual Energy CT in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer
Official title: Applications of Dual Energy CT for Improving Staging and Monitoring of Therapy Response in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dual Energy CT (DECT)
Prostate Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2017-04-13
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish a more accurate and precise way to image (take pictures of) metastatic bone disease in patients with prostate cancer for staging and monitoring response to therapy. More specifically, the study aims to evaluate the capabilities of dual energy CT as a more precise and accurate tool for staging and monitoring of therapy response in patients with osseous metastases from castrate-resistant prostate cancer.

Bone metastases in prostate cancer patients are a clinical and diagnostic challenge to image. Sometimes very small metastatic bone lesions may only become detectable by imaging in response to therapy due to increased bone deposition during the first three months after therapy. Commonly used imaging tests (such as regular CT or bone scan) are unable to reliably tell the difference between increased bone deposition (therapy response) and growth of the lesion (progressive disease). This diagnostic challenge may have profound negative effects on patient management since it may require additional imaging before an accurate determination of tumor response can be made. An appropriate determination of tumor response is needed for appropriate management of prostate cancer. The investigators anticipate that the new imaging tested in this study (called dual energy CT) may provide additional critical information in this clinical and diagnostic challenge.

Approximately 100 people with prostate cancer and metastatic bone disease will take part in this study. At enrollment, three months, and six months, they will will receive a non-enhanced (without contrast) dual energy CT scan of the chest, abdomen and pelvis before receiving their routine, clinical contrast-enhanced CT scan.


Eligibility criteria: Inclusion Criteria:

1. Oncology patients with castrate-resistant prostate cancer planned for therapy with abiraterone acetate or enzalutamide and prednisolone undergoing clinically indicated MDCT (multi-detector computed tomography) of the chest, abdomen and pelvis
2. \> 18 years old
3. Serum creatinine \< 2.0
4. BMI \< 35kg/m\^2
5. Sign informed consent

Exclusion Criteria:

- History of anaphylactoid reaction to iodinated contrast material

Primary outcomes:
measure: Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Sensitivity of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Specificity of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Accuracy of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Reader Performance for Iodine Maps and Fused Images to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Sensitivity of Imaging Approach
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Specificity of Imaging Approach
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Accuracy of Imaging Approach
timeFrame: Duration of CT scan (approximately 5 minutes)
Secondary outcomes:
measure: Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease.
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Reader Performance for Iodine Maps and Fused Images to Diagnose Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Sensitivity of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Specificity of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Accuracy of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Sensitivity of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Specificity of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
timeFrame: Duration of CT scan (approximately 5 minutes)
measure: Accuracy of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
timeFrame: Duration of CT scan (approximately 5 minutes)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
References: