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

NCT ID: NCT02964988

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-10-11

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.

Conditions

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Prostate Cancer Metastatic Bone Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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uPAR PET/CT

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

Group Type EXPERIMENTAL

Injection of PET tracer 68Ga-NOTA-AE105

Intervention Type DRUG

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

PET/CT

Intervention Type DEVICE

Whole body PET/CT

Interventions

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Injection of PET tracer 68Ga-NOTA-AE105

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

Intervention Type DRUG

PET/CT

Whole body PET/CT

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Marie Øbro Fosbøl

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Fosboel, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2016-002184-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AK-2016-PC-1

Identifier Type: -

Identifier Source: org_study_id

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