{
    "info": {
        "nct_id": "NCT05301062",
        "official_title": "China Radium-223 Safety and Effectiveness stuDy In Real World mCRPC paTients",
        "inclusion_criteria": "* Male patient\n* Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases\n* No visceral metastases\n* Decision to initiate treatment with Radium-223 was made independently prior to patient enrollment in the study as per investigator's routine treatment practice\n* Signed informed consent\nHealthy volunteers allowed\nMust be MALE",
        "exclusion_criteria": "* Patients previously treated with Radium-223 for any reason\n* Patients currently treated in any other clinical trials including other Radium-223 studies\n* Patients are planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use\n* Participation in an investigational program with interventions outside of routine clinical practice\n* Patients previously treated with Docetaxel\n* Patients under treatment with Abiraterone Acetate and the Corticosteroids Prednisone or Prednisolone\n\nBesides Inclusion and exclusion criteria, sites should also follow the locally approved Radium-223 product information",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male patient",
            "criterions": [
                {
                    "exact_snippets": "Male patient",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "adenocarcinoma confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "castration resistant adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma type",
                    "requirements": [
                        {
                            "requirement_type": "resistance",
                            "expected_value": "castration resistant"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "prostate"
                        }
                    ]
                },
                {
                    "exact_snippets": "bone metastases",
                    "criterion": "metastasis location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "bone"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No visceral metastases",
            "criterions": [
                {
                    "exact_snippets": "No visceral metastases",
                    "criterion": "visceral metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Decision to initiate treatment with Radium-223 was made independently prior to patient enrollment in the study as per investigator's routine treatment practice",
            "criterions": [
                {
                    "exact_snippets": "Decision to initiate treatment with Radium-223 was made independently prior to patient enrollment",
                    "criterion": "Radium-223 treatment decision",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to patient enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients previously treated with Radium-223 for any reason",
            "criterions": [
                {
                    "exact_snippets": "Patients previously treated with Radium-223",
                    "criterion": "previous treatment with Radium-223",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients currently treated in any other clinical trials including other Radium-223 studies",
            "criterions": [
                {
                    "exact_snippets": "Patients currently treated in any other clinical trials",
                    "criterion": "current treatment in clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including other Radium-223 studies",
                    "criterion": "current treatment in Radium-223 studies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients are planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use",
            "criterions": [
                {
                    "exact_snippets": "systemic concomitant use of other radiopharmaceuticals",
                    "criterion": "use of radiopharmaceuticals",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in an investigational program with interventions outside of routine clinical practice",
            "criterions": [
                {
                    "exact_snippets": "Participation in an investigational program",
                    "criterion": "participation in investigational program",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "interventions outside of routine clinical practice",
                    "criterion": "interventions outside of routine clinical practice",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients previously treated with Docetaxel",
            "criterions": [
                {
                    "exact_snippets": "Patients previously treated with Docetaxel",
                    "criterion": "Docetaxel treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients under treatment with Abiraterone Acetate and the Corticosteroids Prednisone or Prednisolone",
            "criterions": [
                {
                    "exact_snippets": "Patients under treatment with Abiraterone Acetate",
                    "criterion": "Abiraterone Acetate treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Corticosteroids Prednisone or Prednisolone",
                    "criterion": "Corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "Prednisone",
                                "Prednisolone"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Besides Inclusion and exclusion criteria, sites should also follow the locally approved Radium-223 product information",
            "criterions": [
                {
                    "exact_snippets": "sites should also follow the locally approved Radium-223 product information",
                    "criterion": "Radium-223 product information",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": "locally approved"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}