{
    "info": {
        "nct_id": "NCT00634582",
        "official_title": "Phase II Trial of Zemplar (19-nor-1 a,25-Dihydroxyvitamin D2, Paricalcitol Capsule) on Bony Remodeling in Advanced Androgen-Insensitive Prostate Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion:\n\n* Histologically or cytologically confirmed advanced adenocarcinoma of the prostate\n\n  - Radiographically proven bone metastasis from prostate cancer\n* Androgen refractory disease (including anti-androgen withdrawal)\n* Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values > 70 pg/mL, 14 days apart\n* ECOG performance status 0-2\n* Leukocytes ≥ 3,000/μL\n* Absolute neutrophil count ≥ 1,500/μL\n* Platelets ≥ 100,000/μL\n* Total bilirubin normal\n* AST/ALT ≤ 2.5 times upper limit of normal\n* Creatinine clearance ≥ 60 mL/min\n* Calcium normal\n* 25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL\n* 1,25(OH)_2D normal\n* Patients with serum 25-OHD indicative of vitamin D insufficiency are eligible provided they are treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL prior to paricalcitol therapy\n* More than 8 weeks since prior bisphosphonates\n* More than 2 weeks since prior palliative radiotherapy\n* More than 4 weeks since other prior therapy\n* No more than one prior taxane-containing chemotherapy regimen for metastatic disease\n* Multiple lines of prior therapy with hormonal agents allowed\n* Concurrent corticosteroids allowed provided the dose remains stable during the study period\n\nExclusion:\n\n* Underlying metabolic bone disease or vitamin D deficiency\n* History of hypercalcemia\n* Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness) that would interfere with study compliance\n* Concurrent ergocalciferol supplementation\n* Concurrent chemotherapy or hormonal therapy\n* Concurrent investigational or commercial agents for the malignancy"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically or cytologically confirmed advanced adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Radiographically proven bone metastasis from prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Radiographically proven bone metastasis",
                    "criterion": "bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": "radiographically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "bone metastasis from prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "origin of metastasis",
                            "expected_value": "bone"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Androgen refractory disease (including anti-androgen withdrawal)",
            "criterions": [
                {
                    "exact_snippets": "Androgen refractory disease",
                    "criterion": "androgen refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-androgen withdrawal",
                    "criterion": "anti-androgen withdrawal",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values > 70 pg/mL, 14 days apart",
            "criterions": [
                {
                    "exact_snippets": "Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values > 70 pg/mL, 14 days apart",
                    "criterion": "secondary hyperparathyroidism",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "two parathyroid hormone (PTH) values > 70 pg/mL, 14 days apart"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocytes ≥ 3,000/μL",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes ≥ 3,000/μL",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/μL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/μL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000/μL",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000/μL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin normal",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin normal",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST/ALT ≤ 2.5 times upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "AST/ALT ≤ 2.5 times upper limit of normal",
                    "criterion": "AST/ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison to upper limit of normal",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance ≥ 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance ≥ 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calcium normal",
            "criterions": [
                {
                    "exact_snippets": "Calcium normal",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL",
                    "criterion": "25-hydroxyvitamin D (25-OHD) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 1,25(OH)_2D normal",
            "criterions": [
                {
                    "exact_snippets": "1,25(OH)_2D normal",
                    "criterion": "1,25(OH)_2D level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with serum 25-OHD indicative of vitamin D insufficiency are eligible provided they are treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL prior to paricalcitol therapy",
            "criterions": [
                {
                    "exact_snippets": "serum 25-OHD indicative of vitamin D insufficiency",
                    "criterion": "serum 25-OHD",
                    "requirements": [
                        {
                            "requirement_type": "indicative of vitamin D insufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL",
                    "criterion": "25-OHD levels",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "ergocalciferol"
                        },
                        {
                            "requirement_type": "target level",
                            "expected_value": {
                                "operator": "=",
                                "value": 20,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 8 weeks since prior bisphosphonates",
            "criterions": [
                {
                    "exact_snippets": "More than 8 weeks since prior bisphosphonates",
                    "criterion": "time since prior bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 2 weeks since prior palliative radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "More than 2 weeks since prior palliative radiotherapy",
                    "criterion": "time since prior palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since other prior therapy",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since other prior therapy",
                    "criterion": "time since prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No more than one prior taxane-containing chemotherapy regimen for metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "No more than one prior taxane-containing chemotherapy regimen for metastatic disease",
                    "criterion": "prior taxane-containing chemotherapy regimen for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Multiple lines of prior therapy with hormonal agents allowed",
            "criterions": [
                {
                    "exact_snippets": "Multiple lines of prior therapy with hormonal agents allowed",
                    "criterion": "prior therapy with hormonal agents",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple lines"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent corticosteroids allowed provided the dose remains stable during the study period",
            "criterions": [
                {
                    "exact_snippets": "Concurrent corticosteroids allowed ... dose remains stable during the study period",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dose stability",
                            "expected_value": "stable during the study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Underlying metabolic bone disease or vitamin D deficiency",
            "criterions": [
                {
                    "exact_snippets": "Underlying metabolic bone disease",
                    "criterion": "metabolic bone disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vitamin D deficiency",
                    "criterion": "vitamin D deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypercalcemia",
            "criterions": [
                {
                    "exact_snippets": "History of hypercalcemia",
                    "criterion": "hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness) that would interfere with study compliance",
            "criterions": [
                {
                    "exact_snippets": "Concurrent uncontrolled illness",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "co-morbid condition",
                    "criterion": "co-morbid condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent ergocalciferol supplementation",
            "criterions": [
                {
                    "exact_snippets": "Concurrent ergocalciferol supplementation",
                    "criterion": "ergocalciferol supplementation",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent chemotherapy or hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "Concurrent chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent ... hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent investigational or commercial agents for the malignancy",
            "criterions": [
                {
                    "exact_snippets": "Concurrent investigational or commercial agents for the malignancy",
                    "criterion": "use of investigational or commercial agents",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "purpose",
                            "expected_value": "for the malignancy"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion:",
            "criterions": []
        },
        {
            "line": "Exclusion:",
            "criterions": []
        }
    ]
}