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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002184-34 | EudraCT Number |
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Recruitment issues and interim results
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The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in patients with metastatic castration-resistant prostate cancer (mCRPC)
68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/CT will be applied in patients with mCRPC during treatment with Radium-223. PET/CT will be performed before initiation of Radium therapy and after two treatment cycles. The initial semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in metastases as well as the change in these parameters after therapy will be correlated with overall survival and progression free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| uPAR PET/CT | Experimental | Injection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of PET tracer 68Ga-NOTA-AE105 | Drug | Following injection of 68Ga-NOTA-AE105 the patients will be subjected to whole body PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| uPAR PET/CT imaging | Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105 | 1 hour post injection |
| Change in uPAR PET/CT after two cycles of Radium-223 | Change in Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed after 2 cycles of Radium-223 therapy | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| uPAR PET/CT as prognostic factor for overall survival | Patients will be followed for 12 months after uPAR PET/CT | 12 months |
| uPAR PET/CT as prognostic factor for progression free survival | Patients will be followed for 12 months after uPAR PET/CT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Fosboel, MD | Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| PET/CT | Device | Whole body PET/CT |
|
| 12 months |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |