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

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Rigshospitalet

Status and phase

Terminated
Phase 2

Conditions

Prostate Cancer Metastatic
Bone Metastases

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02964988
2016-002184-34 (EudraCT Number)
AK-2016-PC-1

Details and patient eligibility

About

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)

Full 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.

Enrollment

17 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

uPAR PET/CT
Experimental group
Description:
Injection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks.
Treatment:
Device: PET/CT
Drug: Injection of PET tracer 68Ga-NOTA-AE105

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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