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

October 11, 2019 updated by: Marie Øbro Fosbøl, Rigshospitalet, Denmark
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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: uPAR PET/CT
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
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to whole body PET/CT
Device: PET/CT
Whole body PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uPAR PET/CT imaging
Time Frame: 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
1 hour post injection
Change in uPAR PET/CT after two cycles of Radium-223
Time Frame: 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
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Marie Fosboel, MD, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

October 11, 2019

Study Completion (Actual)

October 11, 2019

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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