{
    "info": {
        "nct_id": "NCT00286091",
        "official_title": "A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer",
        "inclusion_criteria": "* men with histologically confirmed prostate cancer\n* bilateral orchiectomy at least 6 months before randomization or continuous androgen-deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before randomization\n* total testosterone level less than 50 ng/dL,\n* hormone refractory (androgen independent) prostate cancer demonstrated during continuous ADT/post-orchiectomy defined as: 3 consecutive prostate-specific antigen (PSA) values with PSA1 < PSA2 < PSA3, each PSA value must be separated by at least 2 weeks, PSA2 and PSA3 greater than or equal to 1.0 ng/mL,\n* high risk for development of bone metastasis defined as PSA value greater than or equal to 8.0 ng/mL, obtained no more than 3 months before randomization OR PSA doubling time less than or equal to 10.0 months\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* prior or current evidence of radiographically detectable bone metastasis\n* known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable)\n* prior or current intravenous bisphosphonate administration",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* men with histologically confirmed prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* bilateral orchiectomy at least 6 months before randomization or continuous androgen-deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before randomization",
            "criterions": [
                {
                    "exact_snippets": "bilateral orchiectomy at least 6 months before randomization",
                    "criterion": "bilateral orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "continuous androgen-deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before randomization",
                    "criterion": "androgen-deprivation therapy (ADT)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* total testosterone level less than 50 ng/dL,",
            "criterions": [
                {
                    "exact_snippets": "total testosterone level less than 50 ng/dL",
                    "criterion": "total testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hormone refractory (androgen independent) prostate cancer demonstrated during continuous ADT/post-orchiectomy defined as: 3 consecutive prostate-specific antigen (PSA) values with PSA1 < PSA2 < PSA3, each PSA value must be separated by at least 2 weeks, PSA2 and PSA3 greater than or equal to 1.0 ng/mL,",
            "criterions": [
                {
                    "exact_snippets": "hormone refractory (androgen independent) prostate cancer",
                    "criterion": "hormone refractory prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "3 consecutive prostate-specific antigen (PSA) values with PSA1 < PSA2 < PSA3",
                    "criterion": "PSA values",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "increasing"
                        }
                    ]
                },
                {
                    "exact_snippets": "each PSA value must be separated by at least 2 weeks",
                    "criterion": "PSA value separation",
                    "requirements": [
                        {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA2 and PSA3 greater than or equal to 1.0 ng/mL",
                    "criterion": "PSA2 and PSA3 values",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* high risk for development of bone metastasis defined as PSA value greater than or equal to 8.0 ng/mL, obtained no more than 3 months before randomization OR PSA doubling time less than or equal to 10.0 months",
            "criterions": [
                {
                    "exact_snippets": "high risk for development of bone metastasis",
                    "criterion": "risk for development of bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA value greater than or equal to 8.0 ng/mL",
                    "criterion": "PSA value",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA doubling time less than or equal to 10.0 months",
                    "criterion": "PSA doubling time",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10.0,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "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": "* prior or current evidence of radiographically detectable bone metastasis",
            "criterions": [
                {
                    "exact_snippets": "prior or current evidence of radiographically detectable bone metastasis",
                    "criterion": "bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "radiographically detectable"
                        },
                        {
                            "requirement_type": "temporal status",
                            "expected_value": [
                                "prior",
                                "current"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable)",
            "criterions": [
                {
                    "exact_snippets": "known prior or current evidence of any metastatic involvement of distant organs",
                    "criterion": "metastatic involvement of distant organs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prior or current intravenous bisphosphonate administration",
            "criterions": [
                {
                    "exact_snippets": "prior or current intravenous bisphosphonate administration",
                    "criterion": "intravenous bisphosphonate administration",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "prior",
                                "current"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}