{
    "info": {
        "nct_id": "NCT03641560",
        "official_title": "A Multicenter Phase 4, Open-label, Single-arm, Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy",
        "inclusion_criteria": "* Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.\n* Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.\n* Subject is being newly initiated on Xtandi treatment (Enzalutamide).\n* Subject has an estimated life expectancy of ≥ 6 months.\n* Subject agrees not to participate in another interventional study while participating in the present study.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.\n* Subject participating or planning to participate in any interventional drug trial during the course of this trial.\n* Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.\n* Subject has any condition which makes the subject unsuitable for study participation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "without neuroendocrine differentiation",
                    "criterion": "neuroendocrine differentiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without ... signet cell ... histology",
                    "criterion": "signet cell histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without ... small cell histology",
                    "criterion": "small cell histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "established diagnosis of metastatic castration-resistant prostate carcinoma",
                    "criterion": "metastatic castration-resistant prostate carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is being newly initiated on Xtandi treatment (Enzalutamide).",
            "criterions": [
                {
                    "exact_snippets": "Subject is being newly initiated on Xtandi treatment (Enzalutamide)",
                    "criterion": "Xtandi treatment (Enzalutamide)",
                    "requirements": [
                        {
                            "requirement_type": "initiation status",
                            "expected_value": "newly initiated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has an estimated life expectancy of ≥ 6 months.",
            "criterions": [
                {
                    "exact_snippets": "estimated life expectancy of ≥ 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject agrees not to participate in another interventional study while participating in the present study.",
            "criterions": [
                {
                    "exact_snippets": "Subject agrees not to participate in another interventional study",
                    "criterion": "participation in another interventional study",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "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": "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": "* Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.",
            "criterions": [
                {
                    "exact_snippets": "not eligible to receive Xtandi as per the locally approved prescribing information",
                    "criterion": "eligibility to receive Xtandi",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject participating or planning to participate in any interventional drug trial during the course of this trial.",
            "criterions": [
                {
                    "exact_snippets": "Subject participating ... in any interventional drug trial",
                    "criterion": "participation in interventional drug trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to participate in any interventional drug trial",
                    "criterion": "planned participation in interventional drug trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.",
            "criterions": [
                {
                    "exact_snippets": "Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.",
                    "criterion": "receipt of investigational study",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has any condition which makes the subject unsuitable for study participation.",
            "criterions": [
                {
                    "exact_snippets": "any condition which makes the subject unsuitable for study participation",
                    "criterion": "suitability for study participation",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}