{
    "info": {
        "nct_id": "NCT01487720",
        "official_title": "A Prosepctive Phase II Study of Gemcitabine and Oxaliplatin in Combination With Prednisolone for the Treatment of Hormone Refracotry Metastatic Prostate Cancer Previously Treated With Docetaxel Regimen",
        "inclusion_criteria": "* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Clinical or radiologic evidence of metastatic disease\n* Documented disease progression during hormone therapy (ADT plus antiandrogen) and no response to ADT withdrawal\n* Docetaxel-refractory disease defined as disease progression documented either during treatment of within 60 days after the cessation of treatment with docetaxel\n* Prior exposure to estramustine or mitoxantrone is allowed\n* KPS ≥ 60\n* No prior radioisotope therapy\n* No prior radiotherapy 25% or more of the bone marrow\n* No peripheral neuropathy grade 2 or worse\n* Adequate organ and bone marrow function\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Other tumor type than adenocarcinoma\n* Presence or history of CNS metastasis\n* Other serious illness or medical conditions",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical or radiologic evidence of metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Clinical or radiologic evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "clinical",
                                "radiologic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented disease progression during hormone therapy (ADT plus antiandrogen) and no response to ADT withdrawal",
            "criterions": [
                {
                    "exact_snippets": "Documented disease progression during hormone therapy (ADT plus antiandrogen)",
                    "criterion": "disease progression during hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no response to ADT withdrawal",
                    "criterion": "response to ADT withdrawal",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Docetaxel-refractory disease defined as disease progression documented either during treatment of within 60 days after the cessation of treatment with docetaxel",
            "criterions": [
                {
                    "exact_snippets": "Docetaxel-refractory disease defined as disease progression documented either during treatment ... with docetaxel",
                    "criterion": "docetaxel-refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "documented either during treatment or within 60 days after cessation of treatment with docetaxel"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior exposure to estramustine or mitoxantrone is allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to estramustine",
                    "criterion": "prior exposure to estramustine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... mitoxantrone",
                    "criterion": "prior exposure to mitoxantrone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* KPS ≥ 60",
            "criterions": [
                {
                    "exact_snippets": "KPS ≥ 60",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radioisotope therapy",
            "criterions": [
                {
                    "exact_snippets": "No prior radioisotope therapy",
                    "criterion": "prior radioisotope therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy 25% or more of the bone marrow",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy 25% or more of the bone marrow",
                    "criterion": "prior radiotherapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No peripheral neuropathy grade 2 or worse",
            "criterions": [
                {
                    "exact_snippets": "No peripheral neuropathy grade 2 or worse",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and bone marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ ... function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 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": "* Other tumor type than adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Other tumor type than adenocarcinoma",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "adenocarcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence or history of CNS metastasis",
            "criterions": [
                {
                    "exact_snippets": "Presence or history of CNS metastasis",
                    "criterion": "CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other serious illness or medical conditions",
            "criterions": [
                {
                    "exact_snippets": "Other serious illness or medical conditions",
                    "criterion": "serious illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other serious illness or medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}