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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: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Bone Metastases
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
 Radiation: fluorine F 18 sodium fluoride
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in 18F-fluoride transport (K1) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2009
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Radiation: fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET scan
Other Names:
  • 18 F-NaF
  • F-18 NaF

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936975

Locations
United States, Pennsylvania
American College of Radiology Imaging Network
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Evan Yu American College of Radiology Imaging Network
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00936975     History of Changes
Other Study ID Numbers: NCI-2010-01292, ACRIN 6687, CDR0000647592, U01CA080098
Study First Received: July 9, 2009
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
 Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Fluorides
Sodium Fluoride
Dasatinib
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013