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| Name | Class |
|---|---|
| Prostate Cancer Foundation | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
| Hospital Vall d'Hebron | OTHER |
| Fundacio Puigvert |
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The skeleton is the most frequent organ of distal metastases in prostate cancer, often representing the only site of metastatic disease. Still, assessment of response and progression to therapies in bone metastases remains a major unmet need, to aid treatment switch decisions, detecting primary/secondary resistance and to optimize drug development. The currently used standard imaging techniques, computed tomography (CT) and bone scintigraphy (BS), do not depict the true extent of bone metastases and are suboptimal in capturing biological changes occurring in response to treatment.
This results in treatment switch decisions too often being based on PSA changes, which is neither a surrogate of survival, nor an optimal response biomarker.Diffusion-weighted imaging (DWI) is a functional magnetic resonance imaging (MRI) technique that studies the movement of water molecules within a tissue and provides valuable information about the tissue microstructure and cellularity. Whole body MRI with DWI is highly accurate for bone metastases detection, outperforming the standard CT and BS and other imaging techniques when assessing bone metastases.
The investigators hypothesise that DWI changes are a response biomarker in bone metastases from metastatic castration resistant prostate cancer (mCRPC); these DWI changes can be detected as early as after 4 weeks of systemic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic prostate cancer | Other | Patients will receive whole-body MRI with diffusion-weighted imaging at baseline and after 4 and 8 weeks of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-Body Diffusion Weighted MRI | Diagnostic Test | MRI at baseline, after four and eight weeks of treatment and at disease progression or treatment discontinuation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in diffusion-weighted MRI as response biomarker | Apparent Diffusion Coefficient (ADC) percentage change in responders vs non-responders to systemic treatment in patients with CRPC and bone metastases | 8 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Early response biomarker identification | Apparent Diffusion Coefficient (ADC) percentage change in responders vs non-responders to systemic treatment in patients with CRPC and bone metastases | 4 weeks after treatment |
| Intra-tumor heterogenous response evaluation |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall d'Hebron Institute of Oncology | Recruiting | Barcelona | 08035 | Spain |
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| OTHER |
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To use diffusion-weighted MRI for identifying anatomic regions of subclonal resistance to systemic treatment and study tumour evolution. |
| 4 and 8 weeks after treatment and at disease progression by standard criteria, on average 1 year |