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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00936975
First received: July 9, 2009
Last updated: June 9, 2014
Last verified: June 2014

July 9, 2009
June 9, 2014
September 2009
August 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00936975 on ClinicalTrials.gov Archive Site
Changes in 18F-fluoride transport (K1) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
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 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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Bone Metastases
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
Radiation: fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET scan
Other Names:
  • 18 F-NaF
  • F-18 NaF
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
Not Provided
August 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00936975
NCI-2010-01292, NCI-2010-01292, CDR0000647592, ACRIN 6687, ACRIN-6687, U01CA080098
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Evan Yu American College of Radiology Imaging Network
National Cancer Institute (NCI)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP