{
    "info": {
        "nct_id": "NCT00657982",
        "official_title": "Phase II Study of RAD001 in a Neoadjuvant Setting in Men With Intermediate or High Risk Prostate Cancer",
        "inclusion_criteria": "1. Histologic documentation of adenocarcinoma of prostate Gleason grade 7-10\n2. No evidence for lymph node or distant disease\n3. No prior RT to pelvis or other regions\n4. Age > 18 years\n5. Performance status ECOG 0-1\n6. ANC >1500/l\n7. Hemoglobin > 9.0 g/dl\n8. Platelets >100,000/l\n9. Total Bilirubin <1.5 x upper limits of normal\n10. AST or ALT < 3 x upper limits of normal\n11. Creatinine < 1.5 x upper limits of normal\n12. Electrolytes within 10% of normal Range\n13. Cholesterol < 300\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Prior hormonal therapy\n2. Prior RT to the pelvis\n3. Currently active second malignancy other than non-melanoma skin cancer\n4. Patients who have any severe and/or uncontrolled medical conditions such as\n\n   1. Unstable angina pectoris, symptomatic congestive heart failure (New York heart association grade 2 or greater failure), myocardial infarction ≤ 6 months prior to randomization, serious uncontrolled cardiac arrhythmia\n   2. Active or uncontrolled severe infection\n   3. Cirrhosis, chronic active hepatitis or chronic persistent hepatitis\n   4. Severely impaired lung function\n5. Evidence of bleeding diathesis or coagulopathy or need of administration of full-dose anti-coagulative(s)\n6. Major surgical procedure, open biopsy or significant trauma within 28 days prior to day 1\n7. Patients with active infection, including inflammation.\n8. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)\n9. Uncontrolled diabetes mellitus as defined by fasting serum glucose >1.5\n10. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent\n11. Patients with a known history of HIV seropositivity",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologic documentation of adenocarcinoma of prostate Gleason grade 7-10",
            "criterions": [
                {
                    "exact_snippets": "Histologic documentation of adenocarcinoma of prostate",
                    "criterion": "adenocarcinoma of prostate",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason grade 7-10",
                    "criterion": "Gleason grade",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. No evidence for lymph node or distant disease",
            "criterions": [
                {
                    "exact_snippets": "No evidence for lymph node ... disease",
                    "criterion": "lymph node disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence for ... distant disease",
                    "criterion": "distant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. No prior RT to pelvis or other regions",
            "criterions": [
                {
                    "exact_snippets": "No prior RT to pelvis",
                    "criterion": "prior RT to pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior RT to ... other regions",
                    "criterion": "prior RT to other regions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age > 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Performance status ECOG 0-1",
            "criterions": [
                {
                    "exact_snippets": "Performance status ECOG 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. ANC >1500/l",
            "criterions": [
                {
                    "exact_snippets": "ANC >1500/l",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Hemoglobin > 9.0 g/dl",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 9.0 g/dl",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Platelets >100,000/l",
            "criterions": [
                {
                    "exact_snippets": "Platelets >100,000/l",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Total Bilirubin <1.5 x upper limits of normal",
            "criterions": [
                {
                    "exact_snippets": "Total Bilirubin <1.5 x upper limits of normal",
                    "criterion": "Total Bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. AST or ALT < 3 x upper limits of normal",
            "criterions": [
                {
                    "exact_snippets": "AST ... < 3 x upper limits of normal",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT < 3 x upper limits of normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Creatinine < 1.5 x upper limits of normal",
            "criterions": [
                {
                    "exact_snippets": "Creatinine < 1.5 x upper limits of normal",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Electrolytes within 10% of normal Range",
            "criterions": [
                {
                    "exact_snippets": "Electrolytes within 10% of normal Range",
                    "criterion": "electrolytes",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within 10% of normal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Cholesterol < 300",
            "criterions": [
                {
                    "exact_snippets": "Cholesterol < 300",
                    "criterion": "cholesterol",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 300,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": [
        {
            "line": "1. Prior hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior RT to the pelvis",
            "criterions": [
                {
                    "exact_snippets": "Prior RT to the pelvis",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "pelvis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Currently active second malignancy other than non-melanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "Currently active second malignancy",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "other than non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who have any severe and/or uncontrolled medical conditions such as",
            "criterions": [
                {
                    "exact_snippets": "severe and/or uncontrolled medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Unstable angina pectoris, symptomatic congestive heart failure (New York heart association grade 2 or greater failure), myocardial infarction ≤ 6 months prior to randomization, serious uncontrolled cardiac arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure (New York heart association grade 2 or greater failure)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "New York heart association grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction ≤ 6 months prior to randomization",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Active or uncontrolled severe infection",
            "criterions": [
                {
                    "exact_snippets": "Active or uncontrolled severe infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "uncontrolled"
                            ]
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Cirrhosis, chronic active hepatitis or chronic persistent hepatitis",
            "criterions": [
                {
                    "exact_snippets": "Cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic active hepatitis",
                    "criterion": "chronic active hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic persistent hepatitis",
                    "criterion": "chronic persistent hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Severely impaired lung function",
            "criterions": [
                {
                    "exact_snippets": "Severely impaired lung function",
                    "criterion": "lung function",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severely impaired"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Evidence of bleeding diathesis or coagulopathy or need of administration of full-dose anti-coagulative(s)",
            "criterions": [
                {
                    "exact_snippets": "Evidence of bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of ... coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "need of administration of full-dose anti-coagulative(s)",
                    "criterion": "administration of full-dose anti-coagulative(s)",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Major surgical procedure, open biopsy or significant trauma within 28 days prior to day 1",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "open biopsy",
                    "criterion": "open biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant trauma",
                    "criterion": "significant trauma",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with active infection, including inflammation.",
            "criterions": [
                {
                    "exact_snippets": "Patients with active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including inflammation",
                    "criterion": "inflammation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)",
                    "criterion": "prior therapy with mTOR inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Uncontrolled diabetes mellitus as defined by fasting serum glucose >1.5",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting serum glucose >1.5",
                    "criterion": "fasting serum glucose",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving chronic treatment with corticosteroids",
                    "criterion": "chronic corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving chronic treatment with ... another immunosuppressive agent",
                    "criterion": "chronic immunosuppressive agent treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with a known history of HIV seropositivity",
            "criterions": [
                {
                    "exact_snippets": "known history of HIV seropositivity",
                    "criterion": "HIV seropositivity",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}