{
    "info": {
        "nct_id": "NCT00587431",
        "official_title": "Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer",
        "inclusion_criteria": "* Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.\n* Patient must have a serum testosterone > 180 ng/dl.\n* Karnofsky performance status (KPS)>_70%.\n* Patients must have adequate organ function as defined by the following\n* laboratory criteria:\n* WBC >_ 3500/mm3\n* ANC >_1500/mm3\n* Platelet count >100,000/mm3\n* Hemoglobin >8.0g/dL\n* Creatinine <1.6mg/dl\n* Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL)\n* SGOT and SGPT If alkaline phosphatase is _< 2.5 x ULN, any elevations in\n* AST/ALT; OR if AST/ALT is _<1.5 x ULN, any elevation in alkaline phos\n* Prior hormonal therapy is allowed as:\n\n  1. Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy).\n  2. One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy).\n* Patients must be at least 18 years of age.\n* Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.\n* Uncontrolled serious active infection.\n* Anticipated survival of less than 3 months.\n* Active CNS or epiduraltumor\n* Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests\n* Peripheral neuropathy >_ grade 3.\n* Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.\n* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.\n* Prior chemotherapy\n* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at MSKCC or SKCCC",
                    "criterion": "confirmation location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "MSKCC",
                                "SKCCC"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have a serum testosterone > 180 ng/dl.",
            "criterions": [
                {
                    "exact_snippets": "serum testosterone > 180 ng/dl",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 180,
                                "unit": "ng/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status (KPS)>_70%.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status (KPS)>_70%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate organ function as defined by the following",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* laboratory criteria:",
            "criterions": [
                {
                    "exact_snippets": "laboratory criteria",
                    "criterion": "laboratory criteria",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC >_ 3500/mm3",
            "criterions": [
                {
                    "exact_snippets": "WBC >_ 3500/mm3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC >_1500/mm3",
            "criterions": [
                {
                    "exact_snippets": "ANC >_1500/mm3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count >100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count >100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin >8.0g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin >8.0g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine <1.6mg/dl",
            "criterions": [
                {
                    "exact_snippets": "Creatinine <1.6mg/dl",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.6,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL)",
            "criterions": [
                {
                    "exact_snippets": "Total Bilirubin WNL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "WNL"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless due to Gilbert's disease",
                    "criterion": "Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other LFTs are WNL",
                    "criterion": "other liver function tests (LFTs)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "WNL"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST/ALT; OR if AST/ALT is _<1.5 x ULN, any elevation in alkaline phos",
            "criterions": [
                {
                    "exact_snippets": "AST/ALT",
                    "criterion": "AST/ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any elevation in alkaline phos",
                    "criterion": "alkaline phosphatase levels",
                    "requirements": [
                        {
                            "requirement_type": "elevation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior hormonal therapy is allowed as:",
            "criterions": [
                {
                    "exact_snippets": "Prior hormonal therapy is allowed",
                    "criterion": "prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy).",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy",
                    "criterion": "neoadjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to radiation therapy or radical pmstatectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "total duration of therapy does not exceed 6 months",
                    "criterion": "total duration of therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy).",
            "criterions": [
                {
                    "exact_snippets": "One cycle of intermittent therapy",
                    "criterion": "intermittent therapy cycle",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum exposure of 6 months",
                    "criterion": "therapy exposure duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be at least 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment",
            "criterions": [
                {
                    "exact_snippets": "signed an informed consent document",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stating that they understand the investigational nature of the proposed treatment",
                    "criterion": "understanding of investigational nature",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiac disease (New York Heart Association Class III/IV)",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "New York Heart Association Class III/IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe debilitating pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe debilitating"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled serious active infection.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled serious active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anticipated survival of less than 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Anticipated survival of less than 3 months.",
                    "criterion": "anticipated survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests",
            "criterions": [
                {
                    "exact_snippets": "Inability or unwillingness to comply with the treatment protocol",
                    "criterion": "compliance with treatment protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability or unwillingness to comply with ... follow-up",
                    "criterion": "compliance with follow-up",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability or unwillingness to comply with ... research tests",
                    "criterion": "compliance with research tests",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral neuropathy >_ grade 3.",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy >_ grade 3",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.",
            "criterions": [
                {
                    "exact_snippets": "history of severe hypersensitivity reaction to drugs formulated with polysorbate 80",
                    "criterion": "hypersensitivity reaction to polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.",
            "criterions": [
                {
                    "exact_snippets": "Men of childbearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to consent to using effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while on treatment and for at least 6 months after completion of the treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while on treatment and for at least 6 months after completion of the treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.",
                    "criterion": "concomitant use of specific substances",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": [
                                "phenytoin",
                                "carbamazepine",
                                "barbiturates",
                                "rifampicin",
                                "phenobarbital",
                                "St. Johns's Wort (hypericum perforatum)",
                                "ketoconazole"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* SGOT and SGPT If alkaline phosphatase is _< 2.5 x ULN, any elevations in",
            "criterions": [
                {
                    "exact_snippets": "SGOT and SGPT",
                    "criterion": "SGOT and SGPT",
                    "requirements": [
                        {
                            "requirement_type": "elevation",
                            "expected_value": "allowed if alkaline phosphatase is < 2.5 x ULN"
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase is < 2.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Active CNS or epiduraltumor",
            "criterions": [
                {
                    "exact_snippets": "Active CNS or epidural tumor",
                    "criterion": "CNS tumor",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active CNS or epidural tumor",
                    "criterion": "epidural tumor",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}