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

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