{
    "info": {
        "nct_id": "NCT03193060",
        "official_title": "A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer",
        "inclusion_criteria": "1. Ability to provide informed consent, complete all study assessments and have complete medical record;\n2. Male aged 18 years and over;\n3. Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;\n4. Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);\n5. More than 26 weeks' life expectancy;\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "1. Patients who are planned to receive radiation therapy;\n2. Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;\n3. Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Ability to provide informed consent, complete all study assessments and have complete medical record;",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complete all study assessments",
                    "criterion": "study assessments",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have complete medical record",
                    "criterion": "medical record",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male aged 18 years and over;",
            "criterions": [
                {
                    "exact_snippets": "Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 years and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of localized or locally advanced prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "localized",
                                "locally advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring immediate hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": "immediate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);",
            "criterions": [
                {
                    "exact_snippets": "Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg",
                    "criterion": "Zoladex prescription",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": [
                                "10.8 mg",
                                "3.6 mg"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in accordance with the terms of marketing authorization",
                    "criterion": "marketing authorization compliance",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as monotherapy or in combination with androgen blockade (CAB)",
                    "criterion": "therapy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "monotherapy",
                                "combination with androgen blockade (CAB)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. More than 26 weeks' life expectancy;",
            "criterions": [
                {
                    "exact_snippets": "More than 26 weeks' life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 26,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who are planned to receive radiation therapy;",
            "criterions": [
                {
                    "exact_snippets": "planned to receive radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "planned treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity to LHRH",
                    "criterion": "hypersensitivity to LHRH",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... its analogues",
                    "criterion": "hypersensitivity to LHRH analogues",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any components of goserelin depot",
                    "criterion": "hypersensitivity to components of goserelin depot",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists.",
            "criterions": [
                {
                    "exact_snippets": "Previous or concurrent hormonal therapy including surgical castration",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "surgical castration"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous or concurrent hormonal therapy including ... androgen blockers",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "androgen blockers"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous or concurrent hormonal therapy including ... oestrogen therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "oestrogen therapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous or concurrent hormonal therapy including ... other LHRH agonists",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "LHRH agonists"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}