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

Phase 2

Terminated

• Conditions: Bone Metastases; Prostate Cancer Metastatic
• Interventions: Drug: Injection of PET tracer 68Ga-NOTA-AE105; Device: PET/CT

• Registration Number: NCT02964988
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-16
• Study Start: 2017-01
• Status Verified: 2019-10
• Primary Completion: 2019-10-11
• Study Completion: 2019-10-11
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
uPAR PET/CT	Injection of PET tracer 68Ga-NOTA-AE105	Injection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks.
uPAR PET/CT	PET/CT	Injection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks.

Primary Outcome Measures

Name	Time	Method
uPAR PET/CT imaging	1 hour post injection	Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
Change in uPAR PET/CT after two cycles of Radium-223	8 weeks	Change in Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed after 2 cycles of Radium-223 therapy

Secondary Outcome Measures

Name	Time	Method
uPAR PET/CT as prognostic factor for progression free survival	12 months	Patients will be followed for 12 months after uPAR PET/CT
uPAR PET/CT as prognostic factor for overall survival	12 months	Patients will be followed for 12 months after uPAR PET/CT

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark