{
    "info": {
        "nct_id": "NCT01036594",
        "official_title": "An Endocrinologically and Pharmacologically Directed Trial of Ketoconazole and Corticosteroids in Castration Resistant Prostate Cancer",
        "inclusion_criteria": "* Histologically confirmed adenocarcinoma of the prostate.\n* Testosterone < 50 ng/dL. Participants must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue if they have not undergone orchiectomy.\n* Progressive non-metastatic or metastatic disease after androgen deprivation. Participants must have EITHER:\n\n  1. Progression as defined by RECIST criteria. OR\n  2. Progressive PSA documented within 4 weeks of enrollment. PSA evidence for progressive prostate cancer consists of a PSA level of at least 5 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart. If the confirmatory PSA value is less than the first documented rising PSA value, then an additional test for rising PSA will be required to document progression.\n* Participants who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen.\n\n  1. Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression.\n  2. For participants receiving flutamide, at least one of the PSA values must be obtained 4 weeks or more after flutamide discontinuation.\n  3. For participants receiving bicalutamide (Casodex) or nilutamide, at least one of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation.\n* Karnofsky Performance Status ≥ 60%.\n* Participants receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment.\n* Participants on stable doses of bisphosphonates may continue on this medication; further, patients may initiate bisphosphonate therapy at the time of ketoconazole initiation.\n* Prior radiation therapy completed ≥ 4 weeks prior to enrollment.\n* Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Bilirubin) must be within normal limits.\n* Absolute Neutrophil Count (ANC) >1500/µl, Platelet count > 100,00/µl, Creatinine <1.5 x upper limit of normal (ULN), Hemoglobin > 8 mg/dl.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior chemotherapy for prostate cancer is not allowed with the exception of cases in which chemotherapy has been administered in a neoadjuvant or adjuvant fashion AND >1 year has elapsed since the administration of this therapy.\n* No prior ketoconazole, abiraterone, aminoglutethimide or corticosteroids for treatment of progressive prostate cancer.\n* No supplements or complementary medicines/botanicals are permitted while on protocol therapy, except for any combination of the following: (conventional multivitamin supplements, selenium, lycopene, soy supplements) No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.\n* No \"currently active\" second malignancy, other than non-melanoma skin cancer.\n* No serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled.\n* No psychiatric illnesses/social situations that would limit compliance\n* No active or uncontrolled autoimmune disease.\n* No adrenal insufficiency as demonstrated by a baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak cortisol >18 µg/dL.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically confirmed adenocarcinoma of the prostate.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed adenocarcinoma of the prostate.",
                        "criterion": "adenocarcinoma of the prostate",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically confirmed adenocarcinoma of the prostate.",
                        "criterion": "adenocarcinoma of the prostate",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Testosterone < 50 ng/dL. Participants must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue if they have not undergone orchiectomy.",
                "criterions": [
                    {
                        "exact_snippets": "Testosterone < 50 ng/dL",
                        "criterion": "testosterone level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participants must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue",
                        "criterion": "primary androgen deprivation",
                        "requirement": {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "if they have not undergone orchiectomy",
                        "criterion": "orchiectomy",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "if they have not undergone orchiectomy",
                    "criterion": "orchiectomy",
                    "requirement": {
                        "requirement_type": "procedure",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Testosterone < 50 ng/dL",
                            "criterion": "testosterone level",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 50,
                                    "unit": "ng/dL"
                                }
                            }
                        },
                        {
                            "exact_snippets": "Participants must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue",
                            "criterion": "primary androgen deprivation",
                            "requirement": {
                                "requirement_type": "continuation",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": {
                    "exact_snippets": "Testosterone < 50 ng/dL",
                    "criterion": "testosterone level",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<",
                            "value": 50,
                            "unit": "ng/dL"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Progressive non-metastatic or metastatic disease after androgen deprivation. Participants must have EITHER:",
                "criterions": [
                    {
                        "exact_snippets": "Progressive non-metastatic or metastatic disease",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "non-metastatic",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "after androgen deprivation",
                        "criterion": "androgen deprivation",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "after"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Progressive non-metastatic or metastatic disease",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "non-metastatic",
                                        "metastatic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "after androgen deprivation",
                                "criterion": "androgen deprivation",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": "after"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Progression as defined by RECIST criteria. OR",
                "criterions": [
                    {
                        "exact_snippets": "Progression as defined by RECIST criteria",
                        "criterion": "progression",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "RECIST criteria"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Progression as defined by RECIST criteria",
                        "criterion": "progression",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "RECIST criteria"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Progressive PSA documented within 4 weeks of enrollment. PSA evidence for progressive prostate cancer consists of a PSA level of at least 5 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart. If the confirmatory PSA value is less than the first documented rising PSA value, then an additional test for rising PSA will be required to document progression.",
                "criterions": [
                    {
                        "exact_snippets": "Progressive PSA documented within 4 weeks of enrollment.",
                        "criterion": "progressive PSA",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "PSA level of at least 5 ng/ml",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/ml"
                            }
                        }
                    },
                    {
                        "exact_snippets": "risen on at least 2 successive occasions, at least 2 weeks apart",
                        "criterion": "PSA level rise",
                        "requirement": {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "occasions"
                            }
                        }
                    },
                    {
                        "exact_snippets": "risen on at least 2 successive occasions, at least 2 weeks apart",
                        "criterion": "PSA level rise",
                        "requirement": {
                            "requirement_type": "interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If the confirmatory PSA value is less than the first documented rising PSA value, then an additional test for rising PSA will be required",
                        "criterion": "confirmatory PSA value",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": "less than first documented rising PSA value"
                        }
                    },
                    {
                        "exact_snippets": "If the confirmatory PSA value is less than the first documented rising PSA value, then an additional test for rising PSA will be required",
                        "criterion": "confirmatory PSA value",
                        "requirement": {
                            "requirement_type": "additional test",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Progressive PSA documented within 4 weeks of enrollment.",
                                "criterion": "progressive PSA",
                                "requirement": {
                                    "requirement_type": "documentation",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "PSA level of at least 5 ng/ml",
                                        "criterion": "PSA level",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 5,
                                                "unit": "ng/ml"
                                            }
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "risen on at least 2 successive occasions, at least 2 weeks apart",
                                                "criterion": "PSA level rise",
                                                "requirement": {
                                                    "requirement_type": "frequency",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 2,
                                                        "unit": "occasions"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "risen on at least 2 successive occasions, at least 2 weeks apart",
                                                "criterion": "PSA level rise",
                                                "requirement": {
                                                    "requirement_type": "interval",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 2,
                                                        "unit": "weeks"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "If the confirmatory PSA value is less than the first documented rising PSA value, then an additional test for rising PSA will be required",
                            "criterion": "confirmatory PSA value",
                            "requirement": {
                                "requirement_type": "comparison",
                                "expected_value": "less than first documented rising PSA value"
                            }
                        },
                        "then_criteria": {
                            "exact_snippets": "If the confirmatory PSA value is less than the first documented rising PSA value, then an additional test for rising PSA will be required",
                            "criterion": "confirmatory PSA value",
                            "requirement": {
                                "requirement_type": "additional test",
                                "expected_value": true
                            }
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen.",
                "criterions": [
                    {
                        "exact_snippets": "Participants who are receiving an antiandrogen as part of primary androgen ablation",
                        "criterion": "antiandrogen therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must demonstrate disease progression following discontinuation of antiandrogen",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "following discontinuation of antiandrogen"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Participants who are receiving an antiandrogen as part of primary androgen ablation",
                    "criterion": "antiandrogen therapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "must demonstrate disease progression following discontinuation of antiandrogen",
                    "criterion": "disease progression",
                    "requirement": {
                        "requirement_type": "timing",
                        "expected_value": "following discontinuation of antiandrogen"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "1. Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression.",
                "criterions": [
                    {
                        "exact_snippets": "Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart",
                        "criterion": "PSA values",
                        "requirement": {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        }
                    },
                    {
                        "exact_snippets": "Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart",
                        "criterion": "PSA values",
                        "requirement": {
                            "requirement_type": "frequency",
                            "expected_value": "2 consecutive"
                        }
                    },
                    {
                        "exact_snippets": "Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart",
                        "criterion": "PSA values",
                        "requirement": {
                            "requirement_type": "interval",
                            "expected_value": "at least 2 weeks apart"
                        }
                    },
                    {
                        "exact_snippets": "documented osseous or soft tissue progression",
                        "criterion": "osseous or soft tissue progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart",
                                        "criterion": "PSA values",
                                        "requirement": {
                                            "requirement_type": "trend",
                                            "expected_value": "rising"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart",
                                        "criterion": "PSA values",
                                        "requirement": {
                                            "requirement_type": "frequency",
                                            "expected_value": "2 consecutive"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart",
                                "criterion": "PSA values",
                                "requirement": {
                                    "requirement_type": "interval",
                                    "expected_value": "at least 2 weeks apart"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "documented osseous or soft tissue progression",
                        "criterion": "osseous or soft tissue progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. For participants receiving flutamide, at least one of the PSA values must be obtained 4 weeks or more after flutamide discontinuation.",
                "criterions": [
                    {
                        "exact_snippets": "participants receiving flutamide",
                        "criterion": "flutamide treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PSA values must be obtained 4 weeks or more after flutamide discontinuation",
                        "criterion": "PSA value timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "participants receiving flutamide",
                    "criterion": "flutamide treatment",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "PSA values must be obtained 4 weeks or more after flutamide discontinuation",
                    "criterion": "PSA value timing",
                    "requirement": {
                        "requirement_type": "timing",
                        "expected_value": {
                            "operator": ">=",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "3. For participants receiving bicalutamide (Casodex) or nilutamide, at least one of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation.",
                "criterions": [
                    {
                        "exact_snippets": "participants receiving bicalutamide (Casodex) or nilutamide",
                        "criterion": "antiandrogen therapy",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": [
                                "bicalutamide",
                                "nilutamide"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "at least one of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation",
                        "criterion": "PSA value timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "or_criteria": [
                        {
                            "exact_snippets": "participants receiving bicalutamide (Casodex) or nilutamide",
                            "criterion": "antiandrogen therapy",
                            "requirement": {
                                "requirement_type": "medication",
                                "expected_value": [
                                    "bicalutamide",
                                    "nilutamide"
                                ]
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "at least one of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation",
                    "criterion": "PSA value timing",
                    "requirement": {
                        "requirement_type": "timing",
                        "expected_value": {
                            "operator": ">=",
                            "value": 6,
                            "unit": "weeks"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Karnofsky Performance Status ≥ 60%.",
                "criterions": [
                    {
                        "exact_snippets": "Karnofsky Performance Status ≥ 60%",
                        "criterion": "Karnofsky Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Karnofsky Performance Status ≥ 60%",
                        "criterion": "Karnofsky Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "Participants receiving any other hormonal therapy ... must discontinue the agent for at least 4 weeks prior to enrollment.",
                        "criterion": "hormonal therapy",
                        "requirement": {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participants receiving ... any dose of megestrol acetate (Megace) ... must discontinue the agent for at least 4 weeks prior to enrollment.",
                        "criterion": "megestrol acetate (Megace)",
                        "requirement": {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participants receiving ... Proscar (finasteride) ... must discontinue the agent for at least 4 weeks prior to enrollment.",
                        "criterion": "Proscar (finasteride)",
                        "requirement": {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participants receiving ... any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES) ... must discontinue the agent for at least 4 weeks prior to enrollment.",
                        "criterion": "herbal product known to decrease PSA levels",
                        "requirement": {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participants receiving ... any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment.",
                        "criterion": "systemic corticosteroid",
                        "requirement": {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants receiving any other hormonal therapy ... must discontinue the agent for at least 4 weeks prior to enrollment.",
                                "criterion": "hormonal therapy",
                                "requirement": {
                                    "requirement_type": "discontinuation period",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants receiving ... any dose of megestrol acetate (Megace) ... must discontinue the agent for at least 4 weeks prior to enrollment.",
                                "criterion": "megestrol acetate (Megace)",
                                "requirement": {
                                    "requirement_type": "discontinuation period",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants receiving ... Proscar (finasteride) ... must discontinue the agent for at least 4 weeks prior to enrollment.",
                                "criterion": "Proscar (finasteride)",
                                "requirement": {
                                    "requirement_type": "discontinuation period",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants receiving ... any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES) ... must discontinue the agent for at least 4 weeks prior to enrollment.",
                                "criterion": "herbal product known to decrease PSA levels",
                                "requirement": {
                                    "requirement_type": "discontinuation period",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants receiving ... any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment.",
                                "criterion": "systemic corticosteroid",
                                "requirement": {
                                    "requirement_type": "discontinuation period",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants on stable doses of bisphosphonates may continue on this medication; further, patients may initiate bisphosphonate therapy at the time of ketoconazole initiation.",
                "criterions": [
                    {
                        "exact_snippets": "Participants on stable doses of bisphosphonates may continue on this medication",
                        "criterion": "bisphosphonate therapy",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable doses"
                        }
                    },
                    {
                        "exact_snippets": "patients may initiate bisphosphonate therapy at the time of ketoconazole initiation",
                        "criterion": "bisphosphonate therapy",
                        "requirement": {
                            "requirement_type": "initiation timing",
                            "expected_value": "at the time of ketoconazole initiation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants on stable doses of bisphosphonates may continue on this medication",
                                "criterion": "bisphosphonate therapy",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": "stable doses"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "patients may initiate bisphosphonate therapy at the time of ketoconazole initiation",
                                "criterion": "bisphosphonate therapy",
                                "requirement": {
                                    "requirement_type": "initiation timing",
                                    "expected_value": "at the time of ketoconazole initiation"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior radiation therapy completed ≥ 4 weeks prior to enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "Prior radiation therapy completed ≥ 4 weeks prior to enrollment.",
                        "criterion": "prior radiation therapy",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior radiation therapy completed ≥ 4 weeks prior to enrollment.",
                        "criterion": "prior radiation therapy",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Bilirubin) must be within normal limits.",
                "criterions": [
                    {
                        "exact_snippets": "Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Bilirubin) must be within normal limits.",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within normal limits"
                        }
                    },
                    {
                        "exact_snippets": "Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Bilirubin) must be within normal limits.",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within normal limits"
                        }
                    },
                    {
                        "exact_snippets": "Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Bilirubin) must be within normal limits.",
                        "criterion": "Bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within normal limits"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Bilirubin) must be within normal limits.",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within normal limits"
                        }
                    },
                    {
                        "exact_snippets": "Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Bilirubin) must be within normal limits.",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within normal limits"
                        }
                    },
                    {
                        "exact_snippets": "Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Bilirubin) must be within normal limits.",
                        "criterion": "Bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within normal limits"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute Neutrophil Count (ANC) >1500/µl, Platelet count > 100,00/µl, Creatinine <1.5 x upper limit of normal (ULN), Hemoglobin > 8 mg/dl.",
                "criterions": [
                    {
                        "exact_snippets": "Absolute Neutrophil Count (ANC) >1500/µl",
                        "criterion": "Absolute Neutrophil Count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "µl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count > 100,00/µl",
                        "criterion": "Platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10000,
                                "unit": "µl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine <1.5 x upper limit of normal (ULN)",
                        "criterion": "Creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin > 8 mg/dl",
                        "criterion": "Hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "mg/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute Neutrophil Count (ANC) >1500/µl",
                        "criterion": "Absolute Neutrophil Count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "µl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count > 100,00/µl",
                        "criterion": "Platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10000,
                                "unit": "µl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine <1.5 x upper limit of normal (ULN)",
                        "criterion": "Creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin > 8 mg/dl",
                        "criterion": "Hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "mg/dl"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* No prior ketoconazole, abiraterone, aminoglutethimide or corticosteroids for treatment of progressive prostate cancer.",
                "criterions": [
                    {
                        "exact_snippets": "No prior ketoconazole",
                        "criterion": "prior ketoconazole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... abiraterone",
                        "criterion": "prior abiraterone",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... aminoglutethimide",
                        "criterion": "prior aminoglutethimide",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... corticosteroids for treatment of progressive prostate cancer",
                        "criterion": "prior corticosteroids for treatment of progressive prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "No prior ketoconazole",
                        "criterion": "prior ketoconazole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... abiraterone",
                        "criterion": "prior abiraterone",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... aminoglutethimide",
                        "criterion": "prior aminoglutethimide",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... corticosteroids for treatment of progressive prostate cancer",
                        "criterion": "prior corticosteroids for treatment of progressive prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No supplements or complementary medicines/botanicals are permitted while on protocol therapy, except for any combination of the following: (conventional multivitamin supplements, selenium, lycopene, soy supplements) No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "No supplements or complementary medicines/botanicals are permitted while on protocol therapy",
                        "criterion": "supplements or complementary medicines/botanicals",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except for any combination of the following: (conventional multivitamin supplements, selenium, lycopene, soy supplements)",
                        "criterion": "allowed supplements",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "conventional multivitamin supplements",
                                "selenium",
                                "lycopene",
                                "soy supplements"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment",
                        "criterion": "prior radiopharmaceuticals",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment",
                        "criterion": "prior radiopharmaceuticals",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "not_criteria": {
                                    "exact_snippets": "No supplements or complementary medicines/botanicals are permitted while on protocol therapy",
                                    "criterion": "supplements or complementary medicines/botanicals",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "except for any combination of the following: (conventional multivitamin supplements, selenium, lycopene, soy supplements)",
                                        "criterion": "allowed supplements",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": [
                                                "conventional multivitamin supplements",
                                                "selenium",
                                                "lycopene",
                                                "soy supplements"
                                            ]
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "not_criteria": {
                                    "exact_snippets": "No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment",
                                    "criterion": "prior radiopharmaceuticals",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            },
                            {
                                "exact_snippets": "No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment",
                                "criterion": "prior radiopharmaceuticals",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 8,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled.",
                "criterions": [
                    {
                        "exact_snippets": "No serious intercurrent infections",
                        "criterion": "serious intercurrent infections",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... nonmalignant medical illnesses that are uncontrolled",
                        "criterion": "uncontrolled nonmalignant medical illnesses",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No serious intercurrent infections",
                        "criterion": "serious intercurrent infections",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... nonmalignant medical illnesses that are uncontrolled",
                        "criterion": "uncontrolled nonmalignant medical illnesses",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No psychiatric illnesses/social situations that would limit compliance",
                "criterions": [
                    {
                        "exact_snippets": "No psychiatric illnesses",
                        "criterion": "psychiatric illnesses",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... social situations that would limit compliance",
                        "criterion": "social situations limiting compliance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No psychiatric illnesses",
                        "criterion": "psychiatric illnesses",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... social situations that would limit compliance",
                        "criterion": "social situations limiting compliance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No active or uncontrolled autoimmune disease.",
                "criterions": [
                    {
                        "exact_snippets": "No active or uncontrolled autoimmune disease.",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No active or uncontrolled autoimmune disease.",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No active or uncontrolled autoimmune disease.",
                                "criterion": "autoimmune disease",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No active or uncontrolled autoimmune disease.",
                                "criterion": "autoimmune disease",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No adrenal insufficiency as demonstrated by a baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak cortisol >18 µg/dL.",
                "criterions": [
                    {
                        "exact_snippets": "No adrenal insufficiency",
                        "criterion": "adrenal insufficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak cortisol >18 µg/dL",
                        "criterion": "peak cortisol level",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "µg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No adrenal insufficiency",
                        "criterion": "adrenal insufficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak cortisol >18 µg/dL",
                        "criterion": "peak cortisol level",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "µg/dL"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Prior chemotherapy for prostate cancer is not allowed with the exception of cases in which chemotherapy has been administered in a neoadjuvant or adjuvant fashion AND >1 year has elapsed since the administration of this therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Prior chemotherapy for prostate cancer is not allowed",
                        "criterion": "prior chemotherapy for prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "with the exception of cases in which chemotherapy has been administered in a neoadjuvant or adjuvant fashion",
                        "criterion": "chemotherapy administration fashion",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "AND >1 year has elapsed since the administration of this therapy",
                        "criterion": "time since chemotherapy administration",
                        "requirement": {
                            "requirement_type": "elapsed time",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Prior chemotherapy for prostate cancer is not allowed",
                            "criterion": "prior chemotherapy for prostate cancer",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "with the exception of cases in which chemotherapy has been administered in a neoadjuvant or adjuvant fashion",
                            "criterion": "chemotherapy administration fashion",
                            "requirement": {
                                "requirement_type": "type",
                                "expected_value": [
                                    "neoadjuvant",
                                    "adjuvant"
                                ]
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "AND >1 year has elapsed since the administration of this therapy",
                    "criterion": "time since chemotherapy administration",
                    "requirement": {
                        "requirement_type": "elapsed time",
                        "expected_value": {
                            "operator": ">",
                            "value": 1,
                            "unit": "year"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No \"currently active\" second malignancy, other than non-melanoma skin cancer.",
                "criterions": [
                    {
                        "exact_snippets": "No \"currently active\" second malignancy",
                        "criterion": "currently active second malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other than non-melanoma skin cancer",
                        "criterion": "non-melanoma skin cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "No \"currently active\" second malignancy",
                                    "criterion": "currently active second malignancy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "other than non-melanoma skin cancer",
                                        "criterion": "non-melanoma skin cancer",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}