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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Terminated
CT.gov ID
NCT02964988
Collaborator
(none)
17
Enrollment
1
Location
1
Arm
33.3
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Injection of PET tracer 68Ga-NOTA-AE105
  • Device: PET/CT
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Oct 11, 2019
Actual Study Completion Date :
Oct 11, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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 Outcome Measures

  1. uPAR PET/CT as prognostic factor for overall survival [12 months]

    Patients will be followed for 12 months after uPAR PET/CT

  2. uPAR PET/CT as prognostic factor for progression free survival [12 months]

    Patients will be followed for 12 months after uPAR PET/CT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie Øbro Fosbøl, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02964988
Other Study ID Numbers:
  • AK-2016-PC-1
  • 2016-002184-34
First Posted:
Nov 16, 2016
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Oct 15, 2019