Stage IV Prostate Cancer Clinical Trial
Official title:
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)
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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