{
    "info": {
        "nct_id": "NCT01284920",
        "official_title": "A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy\n* Progressive disease after prior androgen deprivation therapy (medical or surgical castration)\n* For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel\n* For Expansion Cohort, the patient must have measurable lesions by RECIST\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Metastases in the brain\n* History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years\n* Use of bicalutamide within 6 weeks prior to study\n* Radiation therapy within 12 weeks prior to study\n* Evidence of serious drug hypersensitivity",
        "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 GnRH analogue or a bilateral orchiectomy",
            "criterions": [
                {
                    "exact_snippets": "Ongoing androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "GnRH analogue",
                    "criterion": "GnRH analogue",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral orchiectomy",
                    "criterion": "bilateral orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease after prior androgen deprivation therapy (medical or surgical castration)",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease after prior androgen deprivation therapy",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior androgen deprivation therapy (medical or surgical castration)",
                    "criterion": "prior androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel",
            "criterions": [
                {
                    "exact_snippets": "no more than two prior chemotherapy regimens",
                    "criterion": "prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one regimen containing docetaxel",
                    "criterion": "regimen containing docetaxel",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Expansion Cohort, the patient must have measurable lesions by RECIST",
            "criterions": [
                {
                    "exact_snippets": "measurable lesions by RECIST",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST"
                        }
                    ]
                }
            ]
        },
        {
            "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Metastases in the brain",
            "criterions": [
                {
                    "exact_snippets": "Metastases in the brain",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years",
            "criterions": [
                {
                    "exact_snippets": "History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of bicalutamide within 6 weeks prior to study",
            "criterions": [
                {
                    "exact_snippets": "Use of bicalutamide within 6 weeks prior to study",
                    "criterion": "bicalutamide use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy within 12 weeks prior to study",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy within 12 weeks prior to study",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of serious drug hypersensitivity",
            "criterions": [
                {
                    "exact_snippets": "Evidence of serious drug hypersensitivity",
                    "criterion": "drug hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}