{
    "info": {
        "nct_id": "NCT00064129",
        "official_title": "A Phase I Study of Repetitive Dosing of Anti-CTLA-4 Antibody (Ipilimumab) in Combination With GM-CSF in Patients With Metastatic, Androgen-Independent Prostate Cancer",
        "inclusion_criteria": "* Histologically confirmed prostate cancer\n\n  * Metastatic disease\n* Progressive disease after prior androgen deprivation as defined by at least 1 of the following criteria:\n\n  * Patients with measurable disease must have an increase of at least 20% in the sum of the longest diameter of target lesions OR the appearance of 1 or more new lesions\n  * Patients with nonmeasurable disease must have a positive bone scan and a prostate-specific antigen (PSA) level of at least 5 ng/mL, which has risen on at least 2 successive occasions at least 2 weeks apart*\n\n    * At least 1 PSA level must be obtained at least 4 weeks after flutamide (6 weeks after bicalutamide or nilutamide)\n* Testosterone no greater than 50 ng/dL\n\n  * Patients with no prior orchiectomy must continue luteinizing hormone-releasing hormone agonist therapy\n* No history or radiologic evidence of CNS metastases\n* Performance status - ECOG 0-2\n* At least 12 weeks\n* Absolute neutrophil count greater than 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n* Hemoglobin at least 8 g/dL\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* SGOT and SGPT no greater than 2.5 times ULN\n* Creatinine no greater than 1.5 times ULN\n* No significant cardiovascular disease\n* No New York Heart Association class III or IV congestive heart failure\n* No active angina pectoris\n* No myocardial infarction within the past 6 months\n* Not pregnant or nursing\n* Fertile patients must use effective contraception prior to, during, and for 3 months after study participation\n* No history of autoimmune disease including, but not limited to, any of the following:\n\n  * Autoimmune hemolytic anemia\n  * Ulcerative and hemorrhagic colitis\n  * Endocrine disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism of immune etiology, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency)\n  * Sarcoid granuloma\n  * Myasthenia gravis\n  * Polymyositis\n  * Guillain-Barre syndrome\n  * Systemic lupus erythematosus\n  * Rheumatoid arthritis\n  * Inflammatory bowel disease\n* No other medical or psychiatric illness that would preclude study participation or giving informed consent\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission\n* No prior immunotherapy (e.g., vaccines or investigational)\n* No other concurrent colony-stimulating factors\n* No prior chemotherapy\n* No concurrent chemotherapy\n* See Disease Characteristics\n* At least 4 weeks since prior systemic corticosteroids\n* At least 4 weeks since other prior hormonal therapy, including megestrol and finasteride\n* No concurrent systemic steroid therapy except inhaled or topical steroids\n* No other concurrent hormonal therapy\n\n  * Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed\n* At least 4 weeks since prior radiotherapy and recovered\n* More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 and samarium Sm 153 lexidronam pentasodium)\n* Prior irradiation of a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed\n* No concurrent palliative radiotherapy\n* See Disease Characteristics\n* At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., PC-SPES or saw palmetto)\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease after prior androgen deprivation as defined by at least 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease after prior androgen deprivation",
                    "criterion": "progressive disease after androgen deprivation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with measurable disease must have an increase of at least 20% in the sum of the longest diameter of target lesions OR the appearance of 1 or more new lesions",
            "criterions": [
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "increase of at least 20% in the sum of the longest diameter of target lesions",
                    "criterion": "increase in sum of longest diameter of target lesions",
                    "requirements": [
                        {
                            "requirement_type": "percentage increase",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "appearance of 1 or more new lesions",
                    "criterion": "new lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesions"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 PSA level must be obtained at least 4 weeks after flutamide (6 weeks after bicalutamide or nilutamide)",
            "criterions": [
                {
                    "exact_snippets": "At least 1 PSA level must be obtained",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 4 weeks after flutamide",
                    "criterion": "time since flutamide",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "6 weeks after bicalutamide or nilutamide",
                    "criterion": "time since bicalutamide or nilutamide",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Testosterone no greater than 50 ng/dL",
            "criterions": [
                {
                    "exact_snippets": "Testosterone no greater than 50 ng/dL",
                    "criterion": "testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with no prior orchiectomy must continue luteinizing hormone-releasing hormone agonist therapy",
            "criterions": [
                {
                    "exact_snippets": "no prior orchiectomy",
                    "criterion": "prior orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "must continue luteinizing hormone-releasing hormone agonist therapy",
                    "criterion": "luteinizing hormone-releasing hormone agonist therapy",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history or radiologic evidence of CNS metastases",
            "criterions": [
                {
                    "exact_snippets": "No history ... of CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... radiologic evidence of CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "radiologic evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status - ECOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "Performance status - ECOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "ECOG"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "ECOG"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "At least 12 weeks",
                    "criterion": "duration",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count greater than 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count greater than 1,500/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin at least 8 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin at least 8 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than 1.5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than 1.5 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SGOT and SGPT no greater than 2.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "SGOT ... no greater than 2.5 times ULN",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGPT no greater than 2.5 times ULN",
                    "criterion": "SGPT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.5 times ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant cardiovascular disease",
            "criterions": [
                {
                    "exact_snippets": "No significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No New York Heart Association class III or IV congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No New York Heart Association class III or IV congestive heart failure",
                    "criterion": "New York Heart Association class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 3,
                                "unit": "class"
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 4,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active angina pectoris",
            "criterions": [
                {
                    "exact_snippets": "No active angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No myocardial infarction within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception prior to, during, and for 3 months after study participation",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to, during, and for 3 months after study participation",
                    "criterion": "contraception use duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "prior to, during, and for 3 months after study participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of autoimmune disease including, but not limited to, any of the following:",
            "criterions": [
                {
                    "exact_snippets": "No history of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Autoimmune hemolytic anemia",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune hemolytic anemia",
                    "criterion": "autoimmune hemolytic anemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ulcerative and hemorrhagic colitis",
            "criterions": [
                {
                    "exact_snippets": "Ulcerative ... colitis",
                    "criterion": "ulcerative colitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemorrhagic colitis",
                    "criterion": "hemorrhagic colitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Endocrine disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism of immune etiology, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency)",
            "criterions": [
                {
                    "exact_snippets": "Endocrine disorders (e.g., thyroiditis",
                    "criterion": "thyroiditis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Endocrine disorders (e.g., ... hyperthyroidism",
                    "criterion": "hyperthyroidism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Endocrine disorders (e.g., ... hypothyroidism of immune etiology",
                    "criterion": "hypothyroidism of immune etiology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Endocrine disorders (e.g., ... autoimmune hypophysitis/hypopituitarism",
                    "criterion": "autoimmune hypophysitis/hypopituitarism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Endocrine disorders (e.g., ... adrenal insufficiency",
                    "criterion": "adrenal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sarcoid granuloma",
            "criterions": [
                {
                    "exact_snippets": "Sarcoid granuloma",
                    "criterion": "sarcoid granuloma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myasthenia gravis",
            "criterions": [
                {
                    "exact_snippets": "Myasthenia gravis",
                    "criterion": "myasthenia gravis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Polymyositis",
            "criterions": [
                {
                    "exact_snippets": "Polymyositis",
                    "criterion": "polymyositis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Guillain-Barre syndrome",
            "criterions": [
                {
                    "exact_snippets": "Guillain-Barre syndrome",
                    "criterion": "Guillain-Barre syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic lupus erythematosus",
            "criterions": [
                {
                    "exact_snippets": "Systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rheumatoid arthritis",
            "criterions": [
                {
                    "exact_snippets": "Rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "Inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other medical or psychiatric illness that would preclude study participation or giving informed consent",
            "criterions": [
                {
                    "exact_snippets": "No other medical ... illness that would preclude study participation",
                    "criterion": "medical illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other ... psychiatric illness that would preclude study participation",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other medical or psychiatric illness that would preclude ... giving informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission",
            "criterions": [
                {
                    "exact_snippets": "No other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... stage I or II cancer currently in complete remission",
                    "criterion": "stage I or II cancer",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "complete remission"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior immunotherapy (e.g., vaccines or investigational)",
            "criterions": [
                {
                    "exact_snippets": "No prior immunotherapy",
                    "criterion": "prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "(e.g., vaccines or investigational)",
                    "criterion": "type of immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "vaccines",
                                "investigational"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent colony-stimulating factors",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent colony-stimulating factors",
                    "criterion": "colony-stimulating factors",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see details"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior systemic corticosteroids",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior systemic corticosteroids",
                    "criterion": "systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since other prior hormonal therapy, including megestrol and finasteride",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since other prior hormonal therapy",
                    "criterion": "time since prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including megestrol and finasteride",
                    "criterion": "prior hormonal therapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "specific drugs",
                            "expected_value": [
                                "megestrol",
                                "finasteride"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent systemic steroid therapy except inhaled or topical steroids",
            "criterions": [
                {
                    "exact_snippets": "No concurrent systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except inhaled or topical steroids",
                    "criterion": "inhaled or topical steroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent hormonal therapy",
                    "criterion": "concurrent hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed",
            "criterions": [
                {
                    "exact_snippets": "Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed",
                    "criterion": "hormone administration",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "nondisease-related"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior radiotherapy and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 and samarium Sm 153 lexidronam pentasodium)",
            "criterions": [
                {
                    "exact_snippets": "More than 8 weeks since prior radiopharmaceuticals",
                    "criterion": "time since prior radiopharmaceuticals",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior irradiation of a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior irradiation of a symptomatic lesion",
                    "criterion": "prior irradiation of symptomatic lesion",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "one that may produce disability",
                    "criterion": "lesion that may produce disability",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent palliative radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent palliative radiotherapy",
                    "criterion": "palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see details"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., PC-SPES or saw palmetto)",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior herbal products known to decrease PSA levels",
                    "criterion": "time since prior herbal products",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "herbal products known to decrease PSA levels (e.g., PC-SPES or saw palmetto)",
                    "criterion": "herbal products known to decrease PSA levels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Patients with nonmeasurable disease must have a positive bone scan and a prostate-specific antigen (PSA) level of at least 5 ng/mL, which has risen on at least 2 successive occasions at least 2 weeks apart*",
            "criterions": [
                {
                    "exact_snippets": "nonmeasurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "positive bone scan",
                    "criterion": "bone scan result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate-specific antigen (PSA) level of at least 5 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA level ... has risen on at least 2 successive occasions at least 2 weeks apart",
                    "criterion": "PSA level rise",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}