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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00936975
First received: July 9, 2009
Last updated: June 22, 2015
Last verified: December 2014

July 9, 2009
June 22, 2015
September 2009
June 2014   (final data collection date for primary outcome measure)
  • Changes in 18F-fluoride PET (SUV) - Tumor Bone [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax
  • Changes in 18F-fluoride PET SUV - Normal Bone [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax
  • Changes in 18F-fluoride Ki - Tumor Bone [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone
  • Changes in 18F-fluoride Ki - Normal Bone [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone
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 (by Patlak Flux) - Tumor [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant.
  • Changes in 18F-fluoride Transport (by Patlak Flux) - Normal [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis.
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 ]
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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
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 positron emission tomography (PET) works in evaluating response to dasatinib in patients with prostate cancer and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride 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, measured by 18F-fluoride PET (SUV and Ki), occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.

SECONDARY OBJECTIVES:

I. Determine if changes in 18F-fluoride transport (K1), an indicator of blood flow, and therefore, an indirect marker of angiogenesis, occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.

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
  • Hormone-Resistant Prostate Cancer
  • Metastatic Malignant Neoplasm in the Bone
  • Recurrent Prostate Carcinoma
  • 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. Dasatinib was administered under a concurrent protocol and was not considered part of the intervention on this protocol
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.
 
Completed
18
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be able to provide a written informed consent
  • Men 18 years or older with metastatic castration-resistant prostate cancer enrolling onto the Febbo clinical trial with dasatinib therapy (must meet all inclusion criteria for dasatinib treatment study and comply with requirements of that specific clinical trial)
  • Histologic confirmation of original prostate cancer diagnosis
  • Presence of at least one convincing bone metastasis as defined by bone scintigraphy, computed tomography (CT) scan (magnetic resonance imaging [MRI] if indicated), or plain X-ray
  • Must currently have castrate testosterone levels (< 50 ng/dL) from orchiectomy or maintenance on a luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist

Exclusion Criteria:

  • On the nilutamide-only arm (Arm A of the clinical therapeutic trial)

    • Note: However, if a patient crosses-over from nilutamide at the time of progression to add dasatinib therapy, he may be eligible for 18F-fluoride PET imaging protocol if he meets all inclusion criteria for this trial
  • Any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
  • A serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
  • Expected lifespan of 12 weeks or less
  • Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
  • Initiation of bisphosphonate therapy less than 4 weeks from the first PET scan
  • Radiation treatment to bone less than 4 weeks from first PET scan
  • Radiopharmaceutical treatment to bone less than 4 weeks from first PET scan
  • Treatment with granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte CSF (G-CSF) within 4 weeks prior to first PET scan
  • Inability to lie still for the imaging
  • Weight > 300 lbs. (due to equipment specifications)
Male
18 Years and older   (Adult, Senior)
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, U10CA180820
Not Provided
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Evan Yu ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
December 2014

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