Applications of Dual Energy CT in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer

Duke University

Status: Terminated

Conditions: Dual Energy CT (DECT); Prostate Cancer

Treatments: Diagnostic Test: Dual Energy Computed Tomography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03111914

Pro00078046

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Dual Energy Computed Tomography (DECT)

Other group

Description:

This is a single-arm study. Each patient will receive an unenhanced dual energy CT scan followed by a contrast-enhanced scan as part of clinical routine work up. No change in the contrast material injection protocol will be performed for this this study.

Treatment:

Diagnostic Test: Dual Energy Computed Tomography