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

Metastatic Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03011749
• Other study ID #: H1603551
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 2018

Study information

• Verified date: September 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Prostate Carcinoma
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of FLT in hematological bone marrow		3 months
Secondary	Occurrence of hematological toxicity		12 months