Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
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| First Received Date ICMJE | July 9, 2009 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | January 2100 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in regional fluoride incorporation as measured by 18F-fluoride PET (SUV and Ki) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Changes in regional fluoride incorporation, as measured by fluorine F 18 sodium fluoride positron emission tomography, in both bone metastases and normal bone as a response to treatment with dasatinib [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00936975 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Changes in 18F-fluoride transport (K1) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Changes in fluorine F 18 sodium fluoride transport in both bone metastases and normal bone as a response to treatment with dasatinib [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases | ||||
| Official Title ICMJE | 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) | ||||
| Brief Summary | 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. |
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| Detailed 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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Radiation: fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET scan
Other Names:
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| Study Arm (s) | Experimental: 18F-Fluoride PET
Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib.
Intervention: Radiation: fluorine F 18 sodium fluoride |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | January 2100 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00936975 | ||||
| Other Study ID Numbers ICMJE | NCI-2010-01292, ACRIN 6687, CDR0000647592, U01CA080098 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | National Cancer Institute (NCI) | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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