Clinical trial · Interventional
Applications of Dual Energy CT in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer
Applications of Dual Energy CT for Improving Staging and Monitoring of Therapy Response in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Budgetary Issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dual Energy CT (DECT) | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual Energy Computed Tomography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Dual Energy Computed Tomography (DECT)
- 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.
- interventionNames
- Diagnostic Test: Dual Energy Computed Tomography
Primary outcomes (8)
- 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)
- description
- Feasibility of monitoring metastatic bone disease in prostate cancer patients
- measure
- Sensitivity of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available