We're sorry, but this trial is no longer enrolling volunteers.
A Randomized Open-label Phase IIa Study Evaluating Quantified Bone Scan Response Following Treatment With Radium-223 Dichloride Alone or in Combination With Abiraterone Acetate or Enzalutamide in Subjects With Castration-resistant Prostate Cancer Who Have Bone Metastases
Description
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion Criteria
- Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Known castration-resistant disease
- Serum PSA ≥2 ng/mL (μg/L)
- Multiple skeletal metastases (≥2 hot spots) on bone scan
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
- Life expectancy ≥6 months
- Adequate hematologic, hepatic, and renal function Exclusion Criteria:
- History of visceral metastasis, or visceral metastases
- Malignant lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
- Medical condition that would make prednisone (corticosteroid) use contraindicated
- Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone bid
- Treatment with more than one chemotherapy agent for prostate cancer
- Prior systemic radiotherapy and hemibody external radiotherapy
- History of pituitary or adrenal dysfunction
- Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
- Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
- History of seizures (taking/not taking anticonvulsants), arteriovenous malformation in the brain, head trauma with loss of consciousness
- Central nervous system (CNS) metastases
Sites
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California
- Unknown facility, Los Angeles, California, 90033
- Unknown facility, LaJolla, California, 92037
- Unknown facility, Stanford, California, 94305
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Arizona
- Unknown facility, Scottsdale, Arizona, 85260
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New Mexico
- Unknown facility, Albuquerque, New Mexico, 87109
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Oregon
- Unknown facility, Springfield, Oregon, 97477
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Washington
- Unknown facility, Seattle, Washington, 98109
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Texas
- Unknown facility, San Antonio, Texas, 78229
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Louisiana
- Unknown facility, Shreveport, Louisiana, 71103
- Unknown facility, New Orleans, Louisiana, 70112
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Missouri
- Unknown facility, St. Louis, Missouri, 63110
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Alabama
- Unknown facility, Birmingham, Alabama, 35249
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Indiana
- Unknown facility, Indianapolis, Indiana, 46202
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