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BAY 1812   |   12-1092
Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone Refractory) Prostate Cancer Patients with Bone Metastasis trial

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  1. To provide radium-223 chloride (Ra-223 Cl) to patients diagnosed with castrate-resistant/hormone-refractory prostate cancer (CRPC/HRPC) with symptomatic bone metastasis
  2. To assess the acute and long-term safety of Ra-223 Cl

Inclusion Criteria
  1. Has provided written informed consent. Subjects must be able to understand and be willing to sign the written informed consent form (ICF). A signed ICF must be appropriately obtained prior to the conduct of the any trial- specific procedure.
  2. Age ≥ 18 years
  3. Histologically or cytologically confirmed prostate cancer
  4. Patients diagnosed with symptomatic progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
  5. Symptomatic is defined as either:
    1. Regular (not occasional) use of analgesic medication for cancer related bone pain (≥ level 1; WHO ladder for cancer pain), OR
    2. Treatment with EBRT for bone pain (the EBRT should be within the last 12 weeks before randomization)
  6. Progressive disease is defined either by:
    1. The appearance of new bone lesions. If progression is based on new lesion(s) on bone scan only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; OR
    2. In the absence of a new bone lesions by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL
  7. No intention to use cytotoxic chemotherapy within the next 6 months
  8. Life expectancy ≥ 6 months
  9. ECOG PS 0-2
  10. Adequate hematological, liver and renal function
    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    2. Platelet count ≥ 100 x 10^9/L
    3. Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
    4. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    6. Creatinine ≤ 1.5 x ULN
    7. Albumin > 25 g/L
  11. Willing and able to comply with the protocol, including follow-up visits and examinations

Exclusion Criteria
  1. Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
  2. Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
  3. Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
  4. Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count, and platelets
  5. Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases
  6. Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
  7. Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) or other imaging modality
  8. Presence of brain metastases
  9. Lymphadenopathy exceeding 6 cm in short-axis diameter
  10. Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
  11. Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
  12. Any other serious illness or medical condition, such as but not limited to:
    1. Any infection ≥ NCI-CTCAE v. 4.03 Grade 2
    2. Cardiac failure New York Heart Association (NYHA) III or IV
    3. Crohns disease or ulcerative colitis
    4. Bone marrow dysplasia
  13. Fecal incontinence

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