{
    "info": {
        "nct_id": "NCT00309894",
        "official_title": "Phase II Trial to Assess the Activity of Ketoconazole Plus GM-CSF in Patients With Prostate Cancer Progressive After Androgen Deprivation",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Progressive disease after androgen deprivation AND meets 1 of the following criteria:\n\n  * Measurable disease\n\n    * Measurable lesions ≥ 10 mm with spiral CT\n    * Up to 5 lesions per organ and 10 lesions total should be identified as target lesions\n  * No measurable disease\n\n    * Patients with prostate-specific antigen (PSA)-only disease must have an elevated PSA\n\n      * PSA evidence for progressive disease consists of a PSA level of ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart\n    * Patients with a positive bone scan must also have an elevated PSA\n* Patients who received prior antiandrogen as a part of primary androgen ablation therapy must demonstrate disease progression after discontinuation of the antiandrogen\n\n  * Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values obtained ≥ 2 weeks apart, or documented osseous or soft tissue progression\n\n    * Patients receiving flutamide must have had ≥ 1 of the PSA values obtained ≥ 4 weeks after flutamide discontinuation\n    * Patients receiving bicalutamide or nilutamide must have had ≥ 1 of the PSA values obtained ≥ 6 weeks after antiandrogen discontinuation\n* Testosterone < 50 ng/dL\n* PSA ≥ 5 ng/mL\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* No serious intercurrent infections or nonmalignant uncontrolled medical illnesses\n* No psychiatric illnesses OR social situations that would limit compliance\n* No active or uncontrolled autoimmune disease\n* ALT and AST normal\n* Bilirubin normal\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Creatinine ≤ 1.5 times upper limit or normal (ULN)\n* Hemoglobin ≥ 8 g/dL\n* No other currently active malignancy except for nonmelanoma skin cancer\n\n  * No currently active malignancy defined as therapy completed with ≤ 30% risk of relapse\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Patients must continue primary androgen deprivation therapy with a luteinizing-hormone releasing-hormone (LHRH) analogue if they have not undergone orchiectomy\n* No prior systemic chemotherapy for prostate cancer\n\n  * All other systemic chemotherapy must have been completed ≥ 2 years prior to study\n* No other concurrent chemotherapy, immunotherapy, or radiotherapy\n* Major surgery or radiation therapy completed ≥ 4 weeks prior to study\n* No other concurrent corticosteroids, including routine use antiemetics\n* No prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of progressive prostate cancer\n* No prior immunotherapy (e.g., vaccines or sargramostim GM-CSF)\n* Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal product known to decrease PSA levels [e.g., saw palmetto or PC-SPES], or any systemic corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment and progressive disease must be documented after discontinuation\n* No initiation of bisphosphonate therapy within 1 month prior to starting study therapy\n\n  * Patients on stable doses that show tumor progression are allowed to continue bisphosphonate\n* No concurrent supplements or complementary medicines/botanicals, except any combination of the following:\n\n  * Conventional multivitamin supplements\n  * Selenium\n  * Lycopene\n  * Soy supplements\n  * Vitamin E\n* At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)\n* No other concurrent investigational or commercial anticancer agents or therapies"
    },
    "inclusion_lines": [
        {
            "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 maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease after androgen deprivation AND meets 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease after androgen deprivation",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "after androgen deprivation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable lesions ≥ 10 mm with spiral CT",
            "criterions": [
                {
                    "exact_snippets": "Measurable lesions ≥ 10 mm",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "spiral CT",
                    "criterion": "imaging method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "spiral CT"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Up to 5 lesions per organ and 10 lesions total should be identified as target lesions",
            "criterions": [
                {
                    "exact_snippets": "Up to 5 lesions per organ",
                    "criterion": "lesions per organ",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "lesions"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "10 lesions total",
                    "criterion": "total lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "lesions"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No measurable disease",
            "criterions": [
                {
                    "exact_snippets": "No measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with prostate-specific antigen (PSA)-only disease must have an elevated PSA",
            "criterions": [
                {
                    "exact_snippets": "prostate-specific antigen (PSA)-only disease",
                    "criterion": "PSA-only disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated PSA",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA evidence for progressive disease consists of a PSA level of ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart",
            "criterions": [
                {
                    "exact_snippets": "PSA evidence for progressive disease consists of a PSA level of ≥ 5 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA level ... has risen on ≥ 2 successive occasions, ≥ 2 weeks apart",
                    "criterion": "PSA level rise",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "occasions"
                            }
                        },
                        {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a positive bone scan must also have an elevated PSA",
            "criterions": [
                {
                    "exact_snippets": "positive bone scan",
                    "criterion": "bone scan",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated PSA",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who received prior antiandrogen as a part of primary androgen ablation therapy must demonstrate disease progression after discontinuation of the antiandrogen",
            "criterions": [
                {
                    "exact_snippets": "received prior antiandrogen as a part of primary androgen ablation therapy",
                    "criterion": "prior antiandrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must demonstrate disease progression after discontinuation of the antiandrogen",
                    "criterion": "disease progression after antiandrogen discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values obtained ≥ 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 ≥ 2 weeks apart",
                    "criterion": "PSA values",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        },
                        {
                            "requirement_type": "frequency",
                            "expected_value": "2 consecutive"
                        },
                        {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "documented osseous or soft tissue progression",
                    "criterion": "osseous or soft tissue progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving flutamide must have had ≥ 1 of the PSA values obtained ≥ 4 weeks after flutamide discontinuation",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving flutamide",
                    "criterion": "flutamide treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 1 of the PSA values obtained ≥ 4 weeks after flutamide discontinuation",
                    "criterion": "PSA values after flutamide discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving bicalutamide or nilutamide must have had ≥ 1 of the PSA values obtained ≥ 6 weeks after antiandrogen discontinuation",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving bicalutamide or nilutamide",
                    "criterion": "antiandrogen treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "bicalutamide",
                                "nilutamide"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA values obtained ≥ 6 weeks after antiandrogen discontinuation",
                    "criterion": "PSA values",
                    "requirements": [
                        {
                            "requirement_type": "timing after discontinuation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Testosterone < 50 ng/dL",
            "criterions": [
                {
                    "exact_snippets": "Testosterone < 50 ng/dL",
                    "criterion": "testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA ≥ 5 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "PSA ≥ 5 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status 60-100%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status 60-100%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious intercurrent infections or nonmalignant uncontrolled medical illnesses",
            "criterions": [
                {
                    "exact_snippets": "No serious intercurrent infections",
                    "criterion": "serious intercurrent infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nonmalignant uncontrolled medical illnesses",
                    "criterion": "nonmalignant uncontrolled medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychiatric illnesses OR social situations that would limit compliance",
            "criterions": [
                {
                    "exact_snippets": "No psychiatric illnesses",
                    "criterion": "psychiatric illnesses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... social situations that would limit compliance",
                    "criterion": "social situations limiting compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active or uncontrolled autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "No active or uncontrolled autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT and AST normal",
            "criterions": [
                {
                    "exact_snippets": "ALT and AST normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST normal",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm³",
                    "criterion": "absolute neutrophil count",
                    "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": "* Creatinine ≤ 1.5 times upper limit or normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 times upper limit or normal (ULN)",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 8 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 8 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other currently active malignancy except for nonmelanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other currently active malignancy",
                    "criterion": "currently active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No currently active malignancy defined as therapy completed with ≤ 30% risk of relapse",
            "criterions": [
                {
                    "exact_snippets": "No currently active malignancy",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "therapy completed with ≤ 30% risk of relapse",
                    "criterion": "risk of relapse",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see details"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must continue primary androgen deprivation therapy with a luteinizing-hormone releasing-hormone (LHRH) analogue if they have not undergone orchiectomy",
            "criterions": [
                {
                    "exact_snippets": "Patients must continue primary androgen deprivation therapy",
                    "criterion": "primary androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with a luteinizing-hormone releasing-hormone (LHRH) analogue",
                    "criterion": "luteinizing-hormone releasing-hormone (LHRH) analogue",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if they have not undergone orchiectomy",
                    "criterion": "orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "undergone",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic chemotherapy for prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic chemotherapy for prostate cancer",
                    "criterion": "prior systemic chemotherapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All other systemic chemotherapy must have been completed ≥ 2 years prior to study",
            "criterions": [
                {
                    "exact_snippets": "All other systemic chemotherapy must have been completed ≥ 2 years prior to study",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent chemotherapy, immunotherapy, or radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent ... immunotherapy",
                    "criterion": "concurrent immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent ... radiotherapy",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery or radiation therapy completed ≥ 4 weeks prior to study",
            "criterions": [
                {
                    "exact_snippets": "Major surgery ... completed ≥ 4 weeks prior to study",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy completed ≥ 4 weeks prior to study",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent corticosteroids, including routine use antiemetics",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent corticosteroids",
                    "criterion": "concurrent corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including routine use antiemetics",
                    "criterion": "routine use antiemetics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of progressive prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior ketoconazole ... for treatment of progressive prostate cancer",
                    "criterion": "prior ketoconazole use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... aminoglutethimide ... for treatment of progressive prostate cancer",
                    "criterion": "prior aminoglutethimide use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... corticosteroids for treatment of progressive prostate cancer",
                    "criterion": "prior corticosteroids use for treatment of progressive prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior immunotherapy (e.g., vaccines or sargramostim GM-CSF)",
            "criterions": [
                {
                    "exact_snippets": "No prior immunotherapy",
                    "criterion": "prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "vaccines",
                    "criterion": "prior vaccines",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "sargramostim GM-CSF",
                    "criterion": "prior sargramostim GM-CSF",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal product known to decrease PSA levels [e.g., saw palmetto or PC-SPES], or any systemic corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment and progressive disease must be documented after discontinuation",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal product known to decrease PSA levels [e.g., saw palmetto or PC-SPES], or any systemic corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive disease must be documented after discontinuation",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No initiation of bisphosphonate therapy within 1 month prior to starting study therapy",
            "criterions": [
                {
                    "exact_snippets": "No initiation of bisphosphonate therapy within 1 month prior to starting study therapy",
                    "criterion": "initiation of bisphosphonate therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients on stable doses that show tumor progression are allowed to continue bisphosphonate",
            "criterions": [
                {
                    "exact_snippets": "Patients on stable doses",
                    "criterion": "dose stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "show tumor progression",
                    "criterion": "tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent supplements or complementary medicines/botanicals, except any combination of the following:",
            "criterions": [
                {
                    "exact_snippets": "No concurrent supplements or complementary medicines/botanicals",
                    "criterion": "concurrent supplements or complementary medicines/botanicals",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Conventional multivitamin supplements",
            "criterions": [
                {
                    "exact_snippets": "Conventional multivitamin supplements",
                    "criterion": "multivitamin supplements",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "conventional"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Selenium",
            "criterions": [
                {
                    "exact_snippets": "Selenium",
                    "criterion": "selenium",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lycopene",
            "criterions": [
                {
                    "exact_snippets": "Lycopene",
                    "criterion": "Lycopene",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Soy supplements",
            "criterions": [
                {
                    "exact_snippets": "Soy supplements",
                    "criterion": "soy supplements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vitamin E",
            "criterions": [
                {
                    "exact_snippets": "Vitamin E",
                    "criterion": "Vitamin E",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)",
            "criterions": [
                {
                    "exact_snippets": "At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)",
                    "criterion": "time since prior radiopharmaceuticals",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational or commercial anticancer agents or therapies",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational or commercial anticancer agents or therapies",
                    "criterion": "concurrent anticancer agents or therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}