{
    "info": {
        "nct_id": "NCT00027794",
        "official_title": "Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have maximum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n\n  * Unilateral cT3a, cN0, M0\n* Well or moderately differentiated tumor\n\n  * Gleason score no greater than 7 (4 plus 3 or 3 plus 4)\n* Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 70 and under\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,000/mm^3\n* Platelet count greater than 100,000/mm^3\n* Hemoglobin greater than 9 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times normal\n* ALT or AST less than 3 times normal\n* PT and PTT normal\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular:\n\n* No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy\n* No myocardial infarction within the past 6 months\n\nPulmonary:\n\n* No gross abnormalities on chest x-ray\n\nOther:\n\n* No other disease that would preclude surgery\n* No other prior malignancy except adequately treated basal cell skin cancer\n* No other concurrent primary malignancy\n* No psychological, familial, sociological, or geographical condition that would preclude compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging\n\nRadiotherapy:\n\n* No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity\n\nSurgery:\n\n* No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy"
    },
    "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "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": "* Unilateral cT3a, cN0, M0",
            "criterions": [
                {
                    "exact_snippets": "Unilateral",
                    "criterion": "unilateral",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cT3a",
                    "criterion": "clinical tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT3a"
                        }
                    ]
                },
                {
                    "exact_snippets": "cN0",
                    "criterion": "clinical nodal stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cN0"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Well or moderately differentiated tumor",
            "criterions": [
                {
                    "exact_snippets": "Well or moderately differentiated tumor",
                    "criterion": "tumor differentiation",
                    "requirements": [
                        {
                            "requirement_type": "differentiation level",
                            "expected_value": [
                                "well differentiated",
                                "moderately differentiated"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gleason score no greater than 7 (4 plus 3 or 3 plus 4)",
            "criterions": [
                {
                    "exact_snippets": "Gleason score no greater than 7",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent)",
            "criterions": [
                {
                    "exact_snippets": "Total serum prostate-specific antigen no greater than 20 ng/mL",
                    "criterion": "total serum prostate-specific antigen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 20,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age:",
            "criterions": [
                {
                    "exact_snippets": "Age:",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 70 and under",
            "criterions": [
                {
                    "exact_snippets": "70 and under",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO 0-1",
            "criterions": [
                {
                    "exact_snippets": "WHO 0-1",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy:",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic:",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic:",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC greater than 3,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "WBC greater than 3,000/mm^3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count greater than 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count greater than 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin greater than 9 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin greater than 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 1.5 times normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 1.5 times normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT or AST less than 3 times normal",
            "criterions": [
                {
                    "exact_snippets": "ALT ... less than 3 times normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST less than 3 times normal",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PT and PTT normal",
            "criterions": [
                {
                    "exact_snippets": "PT and PTT normal",
                    "criterion": "PT (Prothrombin Time)",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PT and PTT normal",
                    "criterion": "PTT (Partial Thromboplastin Time)",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.5 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular:",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular:",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy",
            "criterions": [
                {
                    "exact_snippets": "No preexisting uncontrolled cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "signs of cardiac failure",
                    "criterion": "cardiac failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "rhythm disturbances requiring therapy",
                    "criterion": "rhythm disturbances",
                    "requirements": [
                        {
                            "requirement_type": "therapy requirement",
                            "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 occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary:",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary:",
                    "criterion": "pulmonary",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No gross abnormalities on chest x-ray",
            "criterions": [
                {
                    "exact_snippets": "No gross abnormalities on chest x-ray",
                    "criterion": "chest x-ray",
                    "requirements": [
                        {
                            "requirement_type": "gross abnormalities",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other disease that would preclude surgery",
            "criterions": [
                {
                    "exact_snippets": "No other disease that would preclude surgery",
                    "criterion": "other disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on surgery",
                            "expected_value": "does not preclude surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior malignancy except adequately treated basal cell skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other prior malignancy",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except adequately treated basal cell skin cancer",
                    "criterion": "basal cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent primary malignancy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent primary malignancy",
                    "criterion": "concurrent primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychological, familial, sociological, or geographical condition that would preclude compliance",
            "criterions": [
                {
                    "exact_snippets": "No psychological ... condition that would preclude compliance",
                    "criterion": "psychological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... familial ... condition that would preclude compliance",
                    "criterion": "familial condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... sociological ... condition that would preclude compliance",
                    "criterion": "sociological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... geographical condition that would preclude compliance",
                    "criterion": "geographical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy:",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy:",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging",
            "criterions": [
                {
                    "exact_snippets": "No prior hormonal therapy",
                    "criterion": "prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "that would affect assessment of clinical T staging",
                    "criterion": "clinical T staging assessment",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "not affected"
                        }
                    ]
                },
                {
                    "exact_snippets": "that would affect ... margin positivity",
                    "criterion": "margin positivity assessment",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "not affected"
                        }
                    ]
                },
                {
                    "exact_snippets": "that would affect ... definitive pT staging",
                    "criterion": "definitive pT staging assessment",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "not affected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity",
            "criterions": [
                {
                    "exact_snippets": "No prior pelvic radiotherapy",
                    "criterion": "prior pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "that would affect surgical resectability",
                    "criterion": "surgical resectability",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "not affected"
                        }
                    ]
                },
                {
                    "exact_snippets": "and perioperative morbidity",
                    "criterion": "perioperative morbidity",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "not affected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy",
            "criterions": [
                {
                    "exact_snippets": "No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate)",
                    "criterion": "prior surgery in the small pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "that would preclude prostatectomy",
                    "criterion": "surgery precluding prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        }
    ]
}