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

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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
analyzed.

Inclusion Criteria:

- Histologically confirmed prostate cancer:

- Metastatic disease

- Has ≥ 1 convincing bone metastasis by bone scintigraphy, CT scan/MRI, or
plain x-ray

- Castration-resistant disease

- Castrate testosterone levels (< 50 ng/dL)

- Has undergone prior orchiectomy OR is currently on maintenance luteinizing
hormone-releasing hormone (LHRH) agonist or LHRH antagonist

- Scheduled to receive treatment with dasatinib on the Febbo clinical trial

- Life expectancy > 12 weeks

- Able to lie still for imaging

- Weighs ≤ 300 lbs.

- No condition that would alter mental status and preclude the basic understanding
and/or authorization of informed consent

- No serious underlying condition that would otherwise impair the patient's ability to
receive treatment and undergo imaging studies

- No extremely poor IV access that would preclude the placement of a peripheral IV line
for injection of a radiotracer

- At least 4 weeks since prior initiation of bisphosphonate therapy

- At least 4 weeks since prior radiotherapy to the bone

- At least 4 weeks since prior radiopharmaceutical treatment to the bone

- More than 4 weeks since prior GM-CSF or G-CSF