{
    "info": {
        "nct_id": "NCT01606982",
        "official_title": "A Multicenter, Single-arm, Open Label Treatment Protocol to Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy",
        "inclusion_criteria": "* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or orchiectomy\n* At least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel\n* Progressive disease as evidenced by prostate specific antigen (PSA) rise or radiographic or clinical worsening of disease\n* No known or suspected brain metastasis\n* There is no comparable or satisfactory alternative therapy to treat the subject's disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\nMust be MALE",
        "exclusion_criteria": "* History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism\n* History of loss of consciousness or transient ischemic attack within the last 12 months\n* Clinically significant cardiovascular disease\n* Following lab values:\n\n  * Absolute neutrophil count is <1,000/µL\n  * Platelet count is <50,000/µL\n  * Hemoglobin is < 5.6 mmol/L (9 g/dL)\n  * Total bilirubin ≥1.5 x upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2.5 x ULN\n  * Creatinine clearance is less than 30 ml/min by the Cockcroft and Gault formula\n* Subject's conditions suggests that a bone fracture or complication of a bone fracture (such as compression of the spinal cord or other nerves) is likely to occur very soon\n* Subject has participated in a previous clinical study of MDV3100 for which the primary endpoint has not yet been reported (e.g., the PREVAIL trial)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or orchiectomy",
            "criterions": [
                {
                    "exact_snippets": "Ongoing androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist)",
                    "criterion": "GnRH analogue",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "agonist",
                                "antagonist"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "orchiectomy",
                    "criterion": "orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "completed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel",
            "criterions": [
                {
                    "exact_snippets": "At least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer",
                    "criterion": "prior chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "metastatic castration-resistant prostate cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one regimen containing docetaxel",
                    "criterion": "chemotherapy regimen containing docetaxel",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease as evidenced by prostate specific antigen (PSA) rise or radiographic or clinical worsening of disease",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease as evidenced by prostate specific antigen (PSA) rise",
                    "criterion": "prostate specific antigen (PSA)",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rise"
                        }
                    ]
                },
                {
                    "exact_snippets": "Progressive disease as evidenced by ... radiographic ... worsening of disease",
                    "criterion": "radiographic evidence",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "worsening"
                        }
                    ]
                },
                {
                    "exact_snippets": "Progressive disease as evidenced by ... clinical worsening of disease",
                    "criterion": "clinical evidence",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "worsening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known or suspected brain metastasis",
            "criterions": [
                {
                    "exact_snippets": "No known or suspected brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* There is no comparable or satisfactory alternative therapy to treat the subject's disease",
            "criterions": [
                {
                    "exact_snippets": "no comparable or satisfactory alternative therapy to treat the subject's disease",
                    "criterion": "alternative therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 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": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism",
            "criterions": [
                {
                    "exact_snippets": "History of seizure",
                    "criterion": "seizure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any condition that may predispose to seizure",
                    "criterion": "condition predisposing to seizure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "underlying brain injury",
                    "criterion": "underlying brain injury",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary brain tumors",
                    "criterion": "primary brain tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alcoholism",
                    "criterion": "alcoholism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of loss of consciousness or transient ischemic attack within the last 12 months",
            "criterions": [
                {
                    "exact_snippets": "History of loss of consciousness",
                    "criterion": "loss of consciousness",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 12 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack within the last 12 months",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 12 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiovascular disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Following lab values:",
            "criterions": [
                {
                    "exact_snippets": "Following lab values",
                    "criterion": "lab values",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count is <1,000/µL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count is <1,000/µL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count is <50,000/µL",
            "criterions": [
                {
                    "exact_snippets": "Platelet count is <50,000/µL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": "/µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin is < 5.6 mmol/L (9 g/dL)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin is < 5.6 mmol/L (9 g/dL)",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5.6,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≥1.5 x upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≥1.5 x upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... ≥2.5 x ULN",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ≥2.5 x ULN",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance is less than 30 ml/min by the Cockcroft and Gault formula",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance is less than 30 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject's conditions suggests that a bone fracture or complication of a bone fracture (such as compression of the spinal cord or other nerves) is likely to occur very soon",
            "criterions": [
                {
                    "exact_snippets": "Subject's conditions suggests that a bone fracture ... is likely to occur very soon",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "likely to occur very soon"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject's conditions suggests that a ... complication of a bone fracture (such as compression of the spinal cord or other nerves) is likely to occur very soon",
                    "criterion": "complication of a bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "likely to occur very soon"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has participated in a previous clinical study of MDV3100 for which the primary endpoint has not yet been reported (e.g., the PREVAIL trial)",
            "criterions": [
                {
                    "exact_snippets": "Subject has participated in a previous clinical study of MDV3100",
                    "criterion": "previous participation in clinical study of MDV3100",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the primary endpoint has not yet been reported",
                    "criterion": "primary endpoint reporting",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not yet reported"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}