Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
This trial is active, not recruiting.
|Conditions||bone metastases, hormone-resistant prostate cancer, recurrent prostate cancer, stage iv prostate cancer|
|Treatment||fluorine f 18 sodium fluoride|
|Sponsor||National Cancer Institute (NCI)|
|Start date||September 2009|
|End date||August 2011|
|Trial size||24 participants|
|Trial identifier||NCT00936975, ACRIN 6687, ACRIN-6687, CDR0000647592, NCI-2010-01292, U01CA080098|
This phase II trial is studying how well fluorine F 18 sodium fluoride PET works in evaluating response to dasatinib in patients with prostate cancer and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride positron emission tomography (PET), may help doctors predict a patient's response to treatment and help plan the best treatment.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib.
Changes in regional fluoride incorporation as measured by 18F-fluoride PET (SUV and Ki)
time frame: Baseline and 12 weeks
Changes in 18F-fluoride transport (K1)
time frame: Baseline and 12 weeks
Male participants at least 18 years old.
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
|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)|
|Principal investigator||Evan Yu|
|Description||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.|
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