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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



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


  • California

    • Unknown facility, Los Angeles, California, 90033
    • Unknown facility, LaJolla, California, 92037
    • Unknown facility, Stanford, California, 94305
  • Arizona

    • Unknown facility, Scottsdale, Arizona, 85260
  • New Mexico

    • Unknown facility, Albuquerque, New Mexico, 87109
  • Oregon

    • Unknown facility, Springfield, Oregon, 97477
  • Washington

    • Unknown facility, Seattle, Washington, 98109
  • Texas

    • Unknown facility, San Antonio, Texas, 78229
  • Louisiana

    • Unknown facility, Shreveport, Louisiana, 71103
    • Unknown facility, New Orleans, Louisiana, 70112
  • Missouri

    • Unknown facility, St. Louis, Missouri, 63110
  • Alabama

    • Unknown facility, Birmingham, Alabama, 35249
  • Indiana

    • Unknown facility, Indianapolis, Indiana, 46202
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