NCT03011749

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

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

Study Start

First participant enrolled

January 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

January 4, 2017

Last Update Submit

September 10, 2019

Conditions

Metastatic Prostate Carcinoma

Keywords

Radium-223 therapy

Outcome Measures

Primary Outcomes (1)

  • Uptake of FLT in hematological bone marrow

    3 months

Secondary Outcomes (1)

  • Occurrence of hematological toxicity

    12 months

Study Arms (1)

FLT PET/CT

EXPERIMENTAL

FLT PET/CT

Other: FLT PET/CT

Interventions

FLT PET/CTOTHER

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

FLT PET/CT

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
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

January 4, 2017

First Posted

January 5, 2017

Study Start

January 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations

DK(1)