{
    "info": {
        "nct_id": "NCT06334120",
        "official_title": "Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients",
        "inclusion_criteria": "* Male aged ≥19 years\n* Patients with high risk nmCPRC\n\n  * Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL])\n* Patients with mHSPC\n\n  * histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography(CT), or magnetic resonance imaging (MRI).\n  * be candidates for androgen-deprivation therapy and docetaxel\n* Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice\n* Written informed consent from subject or legal representative; assent from subject when appropriate\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 19 Years",
        "exclusion_criteria": "* Patients participating in an investigational program with interventions outside of routine clinical practice\n* Participants with contraindication according to the locally approved prescribing information",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male aged ≥19 years",
            "criterions": [
                {
                    "exact_snippets": "Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥19 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with high risk nmCPRC",
            "criterions": [
                {
                    "exact_snippets": "high risk nmCPRC",
                    "criterion": "nmCPRC",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL])",
            "criterions": [
                {
                    "exact_snippets": "Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL])",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.7,
                                "unit": "nmol/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with mHSPC",
            "criterions": [
                {
                    "exact_snippets": "Patients with mHSPC",
                    "criterion": "mHSPC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography(CT), or magnetic resonance imaging (MRI).",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastases detected on bone scanning, contrast-enhanced computed tomography(CT), or magnetic resonance imaging (MRI)",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "bone scanning",
                                "contrast-enhanced computed tomography(CT)",
                                "magnetic resonance imaging (MRI)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* be candidates for androgen-deprivation therapy and docetaxel",
            "criterions": [
                {
                    "exact_snippets": "candidates for androgen-deprivation therapy",
                    "criterion": "androgen-deprivation therapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "candidates for ... docetaxel",
                    "criterion": "docetaxel candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice",
            "criterions": [
                {
                    "exact_snippets": "decision to initiate treatment with Darolutamide as a first time",
                    "criterion": "Darolutamide treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "initiation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as per investigator's routine treatment practice",
                    "criterion": "investigator's routine treatment practice",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent from subject or legal representative; assent from subject when appropriate",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent from subject or legal representative",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "assent from subject when appropriate",
                    "criterion": "assent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients participating in an investigational program with interventions outside of routine clinical practice",
            "criterions": [
                {
                    "exact_snippets": "Patients participating in an investigational program",
                    "criterion": "participation in investigational program",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "interventions outside of routine clinical practice",
                    "criterion": "interventions",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "outside of routine clinical practice"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with contraindication according to the locally approved prescribing information",
            "criterions": [
                {
                    "exact_snippets": "contraindication according to the locally approved prescribing information",
                    "criterion": "contraindication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}