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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02964988

Enrollment

Registered

2016-11-16

Start date

2017-01-31

Completion date

2019-10-11

Last updated

2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Prostate Cancer Metastatic

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.

Interventions

DRUGInjection of PET tracer 68Ga-NOTA-AE105

Following injection of 68Ga-NOTA-AE105 the patients will be subjected to whole body PET/CT

DEVICEPET/CT

Whole body PET/CT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026