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
  Purpose

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.


Condition Intervention Phase
Hormone-Resistant Prostate Cancer
Metastatic Malignant Neoplasm in the Bone
Recurrent Prostate Carcinoma
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:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: September 2009
Study Completion Date: December 2014
Primary Completion Date: June 2014 (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. Dasatinib was administered under a concurrent protocol and was not considered part of the intervention on this protocol
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, 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.

  Eligibility

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Investigators
Principal Investigator: Evan Yu ECOG-ACRIN Cancer Research Group
  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, NCI-2010-01292, CDR0000647592, ACRIN 6687, ACRIN-6687, U01CA080098, U10CA180820
Study First Received: July 9, 2009
Results First Received: February 20, 2015
Last Updated: June 22, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Second Primary
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Dasatinib
Fluorides
Listerine
Sodium Fluoride
Anti-Infective Agents
Anti-Infective Agents, Local
Cariostatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2015