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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Wisconsin, Madison
With
Millennium Pharmaceuticals, Inc.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
