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
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