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

Primary Purpose

Prostate Cancer Metastatic, Bone Metastases

Status

Terminated

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Injection of PET tracer 68Ga-NOTA-AE105

PET/CT

About this trial

This is an interventional diagnostic trial for Prostate Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

uPAR PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

uPAR PET/CT as prognostic factor for overall survival

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

uPAR PET/CT as prognostic factor for progression free survival

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

Full Information

NCT ID

NCT02964988

First Posted

November 14, 2016

Last Updated

October 11, 2019

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02964988

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Terminated

Why Stopped

Recruitment issues and interim results

Study Start Date

January 2017 (undefined)

Primary Completion Date

October 11, 2019 (Actual)

Study Completion Date

October 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. 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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer Metastatic, Bone Metastases

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

uPAR PET/CT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Injection of PET tracer 68Ga-NOTA-AE105

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PET/CT

Intervention Description

Whole body PET/CT

Primary Outcome Measure Information:

Title

uPAR PET/CT imaging

Description

Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105

Time Frame

1 hour post injection

Title

Change in uPAR PET/CT after two cycles of Radium-223

Description

Change in Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed after 2 cycles of Radium-223 therapy

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

uPAR PET/CT as prognostic factor for overall survival

Description

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

Time Frame

12 months

Title

uPAR PET/CT as prognostic factor for progression free survival

Description

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

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Fosboel, MD

Organizational Affiliation

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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