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Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients

Primary Purpose

Metastatic Prostate Carcinoma

Status

Terminated

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

FLT PET/CT

About this trial

This is an interventional diagnostic trial for Metastatic Prostate Carcinoma focused on measuring Radium-223 therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Metastatic castration resistant prostate cancer
Eligible for Radium-223 therapy
Informed consent

Exclusion Criteria:

Inability to understand study protocol
Extensive metastatic involvement of the axial skeleton ("superscan" on bone scintigraphy)

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLT PET/CT

Arm Description

FLT PET/CT

Outcomes

Primary Outcome Measures

Uptake of FLT in hematological bone marrow

Secondary Outcome Measures

Occurrence of hematological toxicity

Full Information

NCT ID

NCT03011749

First Posted

January 4, 2017

Last Updated

September 10, 2019

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT03011749

Brief Title

Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients

Official Title

Value of FLT PET/CT in Radium-223 Therapy of Patients With Metastatic Castration-resistant Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Study Start Date

January 2017 (undefined)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to investigate whether positron emission tomography (PET) using the tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of hematological toxicity

6. Conditions and Keywords

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

Metastatic Prostate Carcinoma

Keywords

Radium-223 therapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FLT PET/CT

Arm Type

Experimental

Arm Description

FLT PET/CT

Intervention Type

Other

Intervention Name(s)

FLT PET/CT

Intervention Description

FLT PET/CT before first series of Radium-223 and after 2 series

Primary Outcome Measure Information:

Title

Uptake of FLT in hematological bone marrow

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Occurrence of hematological toxicity

Time Frame

12 months

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Metastatic castration resistant prostate cancer Eligible for Radium-223 therapy Informed consent Exclusion Criteria: Inability to understand study protocol Extensive metastatic involvement of the axial skeleton ("superscan" on bone scintigraphy)

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients

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