{
    "info": {
        "nct_id": "NCT06838520",
        "official_title": "A Prospective Study on the Impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on Bone Loss in Prostate Cancer Patients",
        "inclusion_criteria": "1. Age ≥ 18 years, male gender;\n2. Histologically or cytologically confirmed prostate cancer;\n3. Clinical stage of metastatic hormone-sensitive prostate cancer (mHSPC);\n4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;\n5. Life expectancy ≥ 12 months;\n6. Willing and able to provide written informed consent.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Suffering from double primary malignancies.\n2. Having previously received androgen deprivation therapy (ADT) or other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids).\n3. Having osteoporosis at baseline (T-score ≤ -2.5).\n4. Having known bone diseases.\n5. Having spinal metastases confirmed by imaging (e.g., ECT, MRI, CT, or PSMA PET-CT).\n6. Having poor general condition (i.e., ECOG ≥ 4).\n7. Having a life expectancy of less than 12 months.\n8. Having elevated serum PSA levels (≥4 ng/dL) or testosterone levels (≥50 ng/dL) after 6 months of ADT.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Age ≥ 18 years, male gender;",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "male gender",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "male gender",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Histologically or cytologically confirmed prostate cancer;",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Clinical stage of metastatic hormone-sensitive prostate cancer (mHSPC);",
                "criterions": [
                    {
                        "exact_snippets": "Clinical stage of metastatic hormone-sensitive prostate cancer (mHSPC)",
                        "criterion": "clinical stage",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "metastatic hormone-sensitive prostate cancer (mHSPC)"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clinical stage of metastatic hormone-sensitive prostate cancer (mHSPC)",
                        "criterion": "clinical stage",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "metastatic hormone-sensitive prostate cancer (mHSPC)"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Life expectancy ≥ 12 months;",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy ≥ 12 months;",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy ≥ 12 months;",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Willing and able to provide written informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Willing and able to provide written informed consent.",
                        "criterion": "written informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to provide written informed consent.",
                        "criterion": "written informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willing and able to provide written informed consent.",
                        "criterion": "written informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to provide written informed consent.",
                        "criterion": "written informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 80 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Suffering from double primary malignancies.",
                "criterions": [
                    {
                        "exact_snippets": "Suffering from double primary malignancies.",
                        "criterion": "double primary malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Suffering from double primary malignancies.",
                    "criterion": "double primary malignancies",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Having previously received androgen deprivation therapy (ADT) or other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids).",
                "criterions": [
                    {
                        "exact_snippets": "previously received androgen deprivation therapy (ADT)",
                        "criterion": "androgen deprivation therapy (ADT)",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previously received ... other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids)",
                        "criterion": "pharmacological treatments",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": [
                                "denosumab",
                                "bisphosphonates",
                                "corticosteroids"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "previously received androgen deprivation therapy (ADT)",
                        "criterion": "androgen deprivation therapy (ADT)",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previously received ... other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids)",
                        "criterion": "pharmacological treatments",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": [
                                "denosumab",
                                "bisphosphonates",
                                "corticosteroids"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Having known bone diseases.",
                "criterions": [
                    {
                        "exact_snippets": "Having known bone diseases",
                        "criterion": "bone diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Having known bone diseases",
                    "criterion": "bone diseases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Having spinal metastases confirmed by imaging (e.g., ECT, MRI, CT, or PSMA PET-CT).",
                "criterions": [
                    {
                        "exact_snippets": "spinal metastases confirmed by imaging",
                        "criterion": "spinal metastases",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "imaging (e.g., ECT, MRI, CT, or PSMA PET-CT)",
                        "criterion": "imaging",
                        "requirement": {
                            "requirement_type": "methods",
                            "expected_value": [
                                "ECT",
                                "MRI",
                                "CT",
                                "PSMA PET-CT"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "spinal metastases confirmed by imaging",
                        "criterion": "spinal metastases",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "imaging (e.g., ECT, MRI, CT, or PSMA PET-CT)",
                        "criterion": "imaging",
                        "requirement": {
                            "requirement_type": "methods",
                            "expected_value": [
                                "ECT",
                                "MRI",
                                "CT",
                                "PSMA PET-CT"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Having poor general condition (i.e., ECOG ≥ 4).",
                "criterions": [
                    {
                        "exact_snippets": "Having poor general condition (i.e., ECOG ≥ 4)",
                        "criterion": "general condition",
                        "requirement": {
                            "requirement_type": "ECOG score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Having poor general condition (i.e., ECOG ≥ 4)",
                    "criterion": "general condition",
                    "requirement": {
                        "requirement_type": "ECOG score",
                        "expected_value": {
                            "operator": ">=",
                            "value": 4,
                            "unit": "N/A"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Having a life expectancy of less than 12 months.",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy of less than 12 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "life expectancy of less than 12 months",
                    "criterion": "life expectancy",
                    "requirement": {
                        "requirement_type": "duration",
                        "expected_value": {
                            "operator": "<",
                            "value": 12,
                            "unit": "months"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Having elevated serum PSA levels (≥4 ng/dL) or testosterone levels (≥50 ng/dL) after 6 months of ADT.",
                "criterions": [
                    {
                        "exact_snippets": "elevated serum PSA levels (≥4 ng/dL)",
                        "criterion": "serum PSA levels",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "ng/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "testosterone levels (≥50 ng/dL)",
                        "criterion": "testosterone levels",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "after 6 months of ADT",
                        "criterion": "duration of ADT",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "elevated serum PSA levels (≥4 ng/dL)",
                                "criterion": "serum PSA levels",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "ng/dL"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "testosterone levels (≥50 ng/dL)",
                                "criterion": "testosterone levels",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "ng/dL"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "after 6 months of ADT",
                        "criterion": "duration of ADT",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "3. Having osteoporosis at baseline (T-score ≤ -2.5).",
                "criterions": [
                    {
                        "exact_snippets": "Having osteoporosis at baseline",
                        "criterion": "osteoporosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "T-score ≤ -2.5",
                        "criterion": "T-score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": -2.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Having osteoporosis at baseline",
                        "criterion": "osteoporosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "T-score \u0010 -2.5",
                        "criterion": "T-score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": -2.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}