uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Conditions
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Prostate Cancer Metastatic, Bone Metastases

Intervention / Treatment
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* Drug: Injection of PET tracer 68Ga-NOTA-AE105
* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic castration resistant prostate cancer Approved to receive Radium-223 therapy Written and oral consent Exclusion Criteria: Lack of communication skills Other known malignant disease Known allergy towards IMP Severe claustrophobia If a participant exhibits allergic reaction i the IMP, the participant will be excluded from further participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uPAR PET/CT<br>Injection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks. | Drug: Injection of PET tracer 68Ga-NOTA-AE105<br>* Following injection of 68Ga-NOTA-AE105 the patients will be subjected to whole body PET/CT<br>Device: PET/CT<br>* Whole body PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 months |