Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
Condition: Hormone-Resistant Prostate Cancer; Metastatic Malignant Neoplasm in the Bone; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasms
Intervention: Fluorine F 18 Sodium Fluoride
Intervention description: Undergo fluorine F 18 sodium fluoride PET scan
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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)