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

A Pharmacodynamic Study Using NaF PET/CT Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Metastatic Castrate Resistant Prostate Cancer to Bone

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.

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