NaF Positron Emission Tomography/Computed Tomography (PET/CT)Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastasis
Condition: Prostatic Neoplasms; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: TAK-700; Fluorine F 18 Sodium Fluoride; Positron Emission Tomography; Computed Tomography
Intervention description: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles; Undergo NaF F18 PET/CT scan; Undergo 18F NaF PET/CT scan; Undergo 18F NaF PET/CT scan
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate, prostate cancer

Summary:

      The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate
      treatment response in bone metastases in subjects with prostate cancer treated with the
      investigational drug, TAK-700.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients 18 years or older

          -  Voluntary written consent

          -  Histologically proven adenocarcinoma of the prostate

          -  Evidence of radiographic bone metastases

          -  May have received prior chemotherapy for metastatic disease, but prior chemotherapy is
             not a requirement for eligibility

          -  Eastern Cooperative Oncology Group performance status 0-2

          -  Serum testosterone level is less than or equal to 50 ng/dL

          -  Has undergone orchiectomy or plan to continue receiving gonadotropin releasing hormone
             (GnRH) analogue therapy

          -  Adequate organ function as measured by screening laboratory values specified in the
             protocol

          -  Must agree to use appropriate contraceptives prior to study procedures, during
             duration of study participation and for 4 months after last dose of TAK 700

          -  Must be able to lie flat for greater than or equal to 30 minutes during PET/CT imaging

          -  Screening calculated ejection fraction of greater than or equal to 50% by multigated
             radionuclide angiography (MUGA) scan or Echocardiogram

        Exclusion Criteria:

          -  Received Strontium-89, Samarium-153, or other radioisotope within 3 months of
             registration

          -  history of allergic reactions attributed to compounds similar to sodium fluoride F-18
             (NaF)

          -  history of seizure disorder

          -  Known history of brain metastases

          -  Concurrent treatment with any herbal products within 7 days of study entry

          -  Received radiotherapy less than or equal to 4 weeks prior to registration

          -  Known hypersensitivity to TAK-700 or related compounds

          -  Prior therapy for treatment of metastatic castrate resistant prostate cancer with any
             androgen biosynthesis inhibitor or androgen signaling pathway inhibitor such as:
             enzalutamide (MDV-3100), abiraterone, ketoconazole, or aminoglutethimide

          -  Current bladder neck outlet obstruction

          -  Current spinal cord compression

          -  Current bilateral hydronephrosis

          -  History of adrenal insufficiency

          -  History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing
             arrhythmias (over grade 2), thromboembolic events, or any other cardiac condition
             within 6 months prior to first dose of study drug.

          -  Uncontrolled high blood pressure

          -  Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
             hepatitis C

          -  Major surgery less than or equal to 4 weeks before the first dose of study drug

          -  Serious infection less than or equal to 2 weeks before the first dose of study drug

          -  Known gastrointestinal (GI) disease or GI procedure that could interfere with oral
             absorption or tolerance of TAK-700, including difficulty swallowing capsules