Prostate Cancer Metastatic
Conditions
Keywords
response biomarker, functional imaging, MRI
Brief summary
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.
Interventions
DIAGNOSTIC_TESTWhole-Body Diffusion Weighted MRI
MRI at baseline, after four and eight weeks of treatment and at disease progression or treatment discontinuation.
Sponsors
Prostate Cancer Foundation
Instituto de Salud Carlos III
Hospital Vall d'Hebron
Fundacio Puigvert
Vall d'Hebron Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men 18 or over years old. * Patients with castration resistant prostate cancer. * Evidence of bone metastases by any imaging technique. * Patients due to start treatment with abiraterone or enzalutamide. In the exploratory cohorts, we will include patients due to start treatment with other systemic therapies for advanced prostate cancer (A-taxanes, B-radiopharmaceuticals, C-other therapies). * Written (signed and dated) informed consent.
Exclusion criteria
* Contraindications to MRI. * Inability of patient to tolerate whole body MRI (e.g. claustrophobia). * Patients who have received radiotherapy within the last three months and with no bone metastases outside the radiotherapy field.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in diffusion-weighted MRI as response biomarker | 8 weeks after treatment | Apparent Diffusion Coefficient (ADC) percentage change in responders vs non-responders to systemic treatment in patients with CRPC and bone metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early response biomarker identification | 4 weeks after treatment | Apparent Diffusion Coefficient (ADC) percentage change in responders vs non-responders to systemic treatment in patients with CRPC and bone metastases |
| Intra-tumor heterogenous response evaluation | 4 and 8 weeks after treatment and at disease progression by standard criteria, on average 1 year | To use diffusion-weighted MRI for identifying anatomic regions of subclonal resistance to systemic treatment and study tumour evolution. |
Countries
Spain
Outcome results
None listed