{
    "info": {
        "nct_id": "NCT01809691",
        "official_title": "A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer",
        "inclusion_criteria": "* Clinical diagnosis of metastatic prostate cancer.\n* Serum testosterone within institutional limits of normal.\n* PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).\n* DEXA scan within 2 years prior to registration.\n* ECG within 42 days prior to registration and QTc interval ≤ 460 msec.\n* LVEF within 42 days prior to registration and within institutional limits of normal.\n* Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.\n* Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.\n* Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.\n* Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.\n* ≥ 18 years of age.\n* Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known brain metastases.\n* No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.\n* ≥ 6 months since completion of androgen deprivation therapy.\n* Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.\n* Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.\n* ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.\n* Concurrent use of experimental therapy is not allowed.\n* ≥ 30 days since prior medical castration for metastatic prostate cancer.\n* If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.\n* If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).\n* Prior bilateral orchiectomy.\n* Concurrent use of LHRH antagonists (e.g. Degarelix)\n* Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.\n* Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.\n* Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.\n* History of primary and secondary adrenal insufficiency.\n* Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.\n* Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Clinical diagnosis of metastatic prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "Clinical diagnosis of metastatic prostate cancer",
                    "criterion": "metastatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum testosterone within institutional limits of normal.",
            "criterions": [
                {
                    "exact_snippets": "Serum testosterone within institutional limits of normal.",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within institutional limits of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DEXA scan within 2 years prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "DEXA scan within 2 years prior to registration.",
                    "criterion": "DEXA scan",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 years prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECG within 42 days prior to registration and QTc interval ≤ 460 msec.",
            "criterions": [
                {
                    "exact_snippets": "ECG within 42 days prior to registration",
                    "criterion": "ECG",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 42 days prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc interval ≤ 460 msec",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 460,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* LVEF within 42 days prior to registration and within institutional limits of normal.",
            "criterions": [
                {
                    "exact_snippets": "LVEF within 42 days prior to registration and within institutional limits of normal.",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 42 days prior to registration"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": "within institutional limits of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.",
            "criterions": [
                {
                    "exact_snippets": "bilirubin ≤ 2 x institutional upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x institutional ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN",
                    "criterion": "SGOT (AST) and SGPT (ALT) levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x institutional ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT (AST) and SGPT (ALT) ... ≤ 5 x institutional ULN if liver metastases are present",
                    "criterion": "SGOT (AST) and SGPT (ALT) levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x institutional ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function ... creatinine clearance ≥ 40 mL/min.",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function as evidenced by ... absolute neutrophil count (ANC) ≥ 1,500/mcL",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function as evidenced by ... hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function as evidenced by ... platelets ≥ 100,000/mcL",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.",
            "criterions": [
                {
                    "exact_snippets": "Zubrod performance status of 0 - 2",
                    "criterion": "Zubrod performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Zubrod performance status 3 ... if from bone pain only",
                    "criterion": "Zubrod performance status",
                    "requirements": [
                        {
                            "requirement_type": "specific condition",
                            "expected_value": "3 if from bone pain only"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.",
            "criterions": [
                {
                    "exact_snippets": "Men of reproduction potential",
                    "criterion": "reproduction potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterilized (i.e., postvasectomy)",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postvasectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to practice effective barrier contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "effective barrier"
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to abstain from intercourse",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while receiving treatment on this study and for at least 4 months after protocol treatment ends",
                    "criterion": "duration of contraception or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while receiving treatment and for at least 4 months after protocol treatment ends"
                        }
                    ]
                }
            ]
        },
        {
            "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": "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": "* Known brain metastases.",
            "criterions": [
                {
                    "exact_snippets": "Known brain metastases.",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.",
            "criterions": [
                {
                    "exact_snippets": "No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.",
                    "criterion": "prior neoadjuvant and/or adjuvant hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 36,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 6 months since completion of androgen deprivation therapy.",
            "criterions": [
                {
                    "exact_snippets": "≥ 6 months since completion of androgen deprivation therapy",
                    "criterion": "completion of androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy for treatment of metastatic prostate cancer.",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment context",
                            "expected_value": "metastatic prostate cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment context",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.",
            "criterions": [
                {
                    "exact_snippets": "≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.",
                    "criterion": "time since completion of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent use of experimental therapy is not allowed.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of experimental therapy is not allowed.",
                    "criterion": "experimental therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 30 days since prior medical castration for metastatic prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "≥ 30 days since prior medical castration",
                    "criterion": "time since prior medical castration",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic prostate cancer",
                    "criterion": "metastatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.",
            "criterions": [
                {
                    "exact_snippets": "method of castration is a LHRH agonist",
                    "criterion": "method of castration",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "LHRH agonist"
                        }
                    ]
                },
                {
                    "exact_snippets": "patient must be willing to continue the use of LHRH",
                    "criterion": "willingness to continue LHRH",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "add bicalutamide or TAK-700 during protocol treatment",
                    "criterion": "addition of medication",
                    "requirements": [
                        {
                            "requirement_type": "medications",
                            "expected_value": [
                                "bicalutamide",
                                "TAK-700"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).",
            "criterions": [
                {
                    "exact_snippets": "If the patient was on an antiandrogen (e.g. bicalutamide, flutamide)",
                    "criterion": "current antiandrogen medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient must be willing to switch over to bicalutamide or TAK-700",
                    "criterion": "willingness to switch medication",
                    "requirements": [
                        {
                            "requirement_type": "expected medications",
                            "expected_value": [
                                "bicalutamide",
                                "TAK-700"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior bilateral orchiectomy.",
            "criterions": [
                {
                    "exact_snippets": "Prior bilateral orchiectomy",
                    "criterion": "bilateral orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent use of LHRH antagonists (e.g. Degarelix)",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of LHRH antagonists",
                    "criterion": "LHRH antagonists use",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.",
            "criterions": [
                {
                    "exact_snippets": "Grade III/IV cardiac disease (as defined by the NYHA Criteria)",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "thromboembolic event",
                    "criterion": "thromboembolic event",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic ... during the Screening visit)",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "systolic",
                            "expected_value": {
                                "operator": ">",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension ... at 2 separate measurements no more than 60 minutes apart during the Screening visit",
                    "criterion": "blood pressure measurements",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">=2"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension ... despite appropriate medical therapy",
                    "criterion": "hypertension control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of primary and secondary adrenal insufficiency.",
            "criterions": [
                {
                    "exact_snippets": "History of primary ... adrenal insufficiency.",
                    "criterion": "primary adrenal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... secondary adrenal insufficiency.",
                    "criterion": "secondary adrenal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to TAK-700",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "TAK-700"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity ... to TAK-700 metabolites",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "TAK-700 metabolites"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity ... to bicalutamide",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "bicalutamide"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity ... to LHRH agonists",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "LHRH agonists"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal (GI) disease",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "GI procedure that could interfere with the GI absorption or tolerance of TAK-700",
                    "criterion": "GI procedure",
                    "requirements": [
                        {
                            "requirement_type": "interference with absorption or tolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "difficulty swallowing oral medications",
                    "criterion": "difficulty swallowing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.",
            "criterions": [
                {
                    "exact_snippets": "No other prior malignancy is allowed",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated Stage I or II cancer from which the patient is currently in complete remission",
                    "criterion": "Stage I or II cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        },
                        {
                            "requirement_type": "remission status",
                            "expected_value": "complete remission"
                        }
                    ]
                },
                {
                    "exact_snippets": "any other cancer from which the patient has been disease-free for 5 years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).",
            "criterions": [
                {
                    "exact_snippets": "PSA ≥ 2 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 90 days prior to initiation of androgen deprivation therapy",
                    "criterion": "timeframe for PSA measurement (early induction)",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 90 days prior to initiation of androgen deprivation therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to registration (for late induction)",
                    "criterion": "timeframe for PSA measurement (late induction)",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "prior to registration"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Prior or concurrent therapy with ketoconazole",
                    "criterion": "therapy with ketoconazole",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior or concurrent therapy with aminoglutethimide",
                    "criterion": "therapy with aminoglutethimide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior or concurrent therapy with abiraterone acetate",
                    "criterion": "therapy with abiraterone acetate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior or concurrent therapy with enzalutamide (MDV3100)",
                    "criterion": "therapy with enzalutamide (MDV3100)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent megestrol for hot flashes is allowed",
                    "criterion": "concurrent megestrol for hot flashes",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.",
            "criterions": [
                {
                    "exact_snippets": "Known human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active chronic hepatitis B or C",
                    "criterion": "chronic hepatitis B or C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "life-threatening illness unrelated to cancer",
                    "criterion": "life-threatening illness unrelated to cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study",
                    "criterion": "serious medical or psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "potential interference with study participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}