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)
I. Determine if changes in regional fluoride incorporation (SUV and Ki), as measured by
fluorine F 18 sodium fluoride positron emission tomography, occur in both bone metastases
and normal bone as a response to treatment with dasatinib in patients with
castration-resistant prostate cancer and bone metastases.
I. Determine if changes in fluorine F 18 sodium fluoride transport (Kl) occur in both bone
metastases and normal bone as a response to treatment with dasatinib in these patients.
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Changes in regional fluoride incorporation as measured by 18F-fluoride PET (SUV and Ki)
Baseline and 12 weeks
American College of Radiology Imaging Network
United States: Food and Drug Administration
|American College of Radiology Imaging Network||Philadelphia, Pennsylvania 19103|