Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC

Who can take part

• Age > 18 year
• Histologic proof of Castrate Resistant Prostate Cancer with Bone Metastasis
• Systemic steroids are only allowed if needed for hormonal therapy
• Previous radiation therapy must have been completed more than four weeks prior to enrollment into this study, unless subjects are under radiotherapy as a rescue therapy. Subjects must have recovered from all side effects
• The last dose of chemotherapy must have been completed at least four weeks prior to enrollment into this study, and subjects must have recovered from all side effects
• Subjects must have a performance status of 0-2 by the ECOG Scale
• Subjects must have pretreatment (obtained < 7 days prior to treatment) granulocyte count of > 2,000/μL, platelet count of > 100,000/μL, WBC > 3,000/μL, hemoglobin ≥ 10.0 g/dL, serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL, and ALT/AST not more than 3x the upper limit of normal (or not more than 5x if the elevation is due to liver metastases)
• Subjects must be normo-calcemic upon study entry
• Subjects must be Vitamin D sufficient upon study entry, which is defined as 25(OH)D serum level >20 ng/mL (50 nmol/L) according to a document composed by the Food and Nutrition Board of the Institute of Medicine, USA. If the subject is Vitamin D insufficient or deficient, then a loading dose of Vitamin D3 will be administered as follows:; If the serum 25(OH)D level is 12-20 ng/mL (30-50 nmol/L) then a loading oral dose of 50,000 IU of Vitamin D3 should be administered twice with 3-5 days in between the doses; If the serum 25(OH)D level is ≤ 12 ng/mL (30 nmol/L), then a loading oral dose of 50,000 IU of Vitamin D3 will be administered three times with 3-5 days in between the doses. Serum 25(OH)D levels will be checked 1-2 weeks following the last loading
• Regardless of Vitamin D levels, all subjects will receive a daily maintenance dose of 1000 IU Vitamin D3, which should be taken in the morning with breakfast
• Estimated life expectancy of > 3 months
• Subjects must be accessible for follow-up
• Written informed consent will be obtained

Who cannot take part

• Concurrent treatment with acute anticancer therapy
• Hormonal and corticosteroid therapies for Skeletal Related Events are not allowed
• Major surgery within 4 weeks of anticipated inception of AMOR-1therapy
• Any illness or condition deemed by the investigator to contra-indicate treatment with AMOR-1 or ZA or Denosumab
• Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of therapy
• Psychiatric disorders rendering subjects incapable of complying with the requirements of the protocol
• Active cancer treatment except hormonal
• Hypersensitivity to ZA or Denosumab or Abiraterone acetate or Enzalutamide, or to any bisphosphonates or to any of the following excipients: Mannitol and Sodium citrate
• Sarcoidosis
• Hypercalcemia
• Hypophosphatemia
• Hypoparathyroidism/Hyperparathyroidism