Clinical Trials Directory

Trials / Completed

CompletedNCT00936975

Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases

A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men With Castration-Resistant Prostate Cancer and Bone Metastases (BMS #180-279)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
18 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well fluorine F 18 sodium fluoride positron emission tomography (PET) works in evaluating response to dasatinib in patients with prostate cancer and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride PET, may help doctors predict a patient's response to treatment and help plan the best treatment.

Detailed description

PRIMARY OBJECTIVES: I. Determine if changes in regional fluoride incorporation, measured by 18F-fluoride PET (SUV and Ki), occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib. SECONDARY OBJECTIVES: I. Determine if changes in 18F-fluoride transport (K1), an indicator of blood flow, and therefore, an indirect marker of angiogenesis, occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib. OUTLINE: This is a multicenter study. Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. PET parameters (SUV, Ki, and Kl) are also analyzed.

Conditions

Interventions

TypeNameDescription
RADIATIONFluorine F 18 Sodium FluorideUndergo fluorine F 18 sodium fluoride PET scan

Timeline

Start date
2009-09-01
Primary completion
2014-06-01
Completion
2014-12-01
First posted
2009-07-10
Last updated
2015-07-16
Results posted
2015-07-16

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00936975. Inclusion in this directory is not an endorsement.