NCT02964988

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

2.8 years

First QC Date

November 14, 2016

Last Update Submit

October 11, 2019

Conditions

Prostate Cancer MetastaticBone Metastases

Outcome Measures

Primary Outcomes (2)

  • uPAR PET/CT imaging

    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

    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 Outcomes (2)

  • uPAR PET/CT as prognostic factor for overall survival

    12 months

  • uPAR PET/CT as prognostic factor for progression free survival

    12 months

Study Arms (1)

uPAR PET/CT

EXPERIMENTAL

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-AE105Device: PET/CT

Interventions

Injection of PET tracer 68Ga-NOTA-AE105DRUG

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

uPAR PET/CT
PET/CTDEVICE

Whole body PET/CT

uPAR PET/CT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic castration resistant prostate cancer
  • Approved to receive Radium-223 therapy
  • Written and oral consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Marie Fosboel, MD

    Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 16, 2016

Study Start

January 1, 2017

Primary Completion

October 11, 2019

Study Completion

October 11, 2019

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations

DK(1)