{
    "info": {
        "nct_id": "NCT00321620",
        "official_title": "A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer",
        "inclusion_criteria": "* Men >/= 18 years of age with histologically confirmed prostate cancer\n* Radiographic evidence of at least one bone metastasis\n* Failure of at least one hormonal therapy as evidenced by a rising PSA\n* Serum testosterone level of <50 ng/dL\n* ECOG PS 0, 1, or 2\n* Adequate organ function\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Current or prior IV bisphosphonate administration\n* Current or prior oral bisphosphonates for bone mets\n* Life expectancy of less than 6 months",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Men >/= 18 years of age with histologically confirmed prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation_method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiographic evidence of at least one bone metastasis",
            "criterions": [
                {
                    "exact_snippets": "Radiographic evidence of at least one bone metastasis",
                    "criterion": "bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "radiographic"
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "metastasis"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failure of at least one hormonal therapy as evidenced by a rising PSA",
            "criterions": [
                {
                    "exact_snippets": "Failure of at least one hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rising PSA",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum testosterone level of <50 ng/dL",
            "criterions": [
                {
                    "exact_snippets": "Serum testosterone level of <50 ng/dL",
                    "criterion": "serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG PS 0, 1, or 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS 0, 1, or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Current or prior IV bisphosphonate administration",
            "criterions": [
                {
                    "exact_snippets": "Current or prior IV bisphosphonate administration",
                    "criterion": "IV bisphosphonate administration",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "current",
                                "prior"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or prior oral bisphosphonates for bone mets",
            "criterions": [
                {
                    "exact_snippets": "Current or prior oral bisphosphonates",
                    "criterion": "oral bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": [
                                "current",
                                "prior"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "bone mets",
                    "criterion": "bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of less than 6 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of less than 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}