{
    "info": {
        "nct_id": "NCT06634173",
        "official_title": "The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer",
        "inclusion_criteria": "* Male, aged ≥ 18 years;\n* WHO performance status 0, 1 or 2;\n* Written informed consent;\n* Biopsy-proven newly diagnosed PCa;\n* International Society of Urological Pathology (ISUP) grade group (GG) ≥ 3 and/or PSA ≥ 20 ng/ml and/or ≥cT3a.\n\nIf all of the criteria above are met, a subject must also meet all of the following subgroup specific criteria:\n\nGroup 1 (n=15):\n\n- PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or distant metastases.\n\nGroup 2 (n=15):\n\n* PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or distant metastases;\n* Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti ≥40%) [22];\n* Scheduled for (laparoscopic) prostatectomy including ePLND.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known second malignant disease that may complicate image interpretation.\n* Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Male, aged ≥ 18 years;",
                "criterions": [
                    {
                        "exact_snippets": "Male",
                        "criterion": "gender",
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                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    },
                    {
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                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
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                        }
                    },
                    {
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                                "unit": "years"
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                        }
                    }
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            }
        },
        {
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                "line": "* WHO performance status 0, 1 or 2;",
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                    {
                        "exact_snippets": "WHO performance status 0, 1 or 2",
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                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "WHO performance status 0, 1 or 2",
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                            "requirement_type": "value",
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                                "0",
                                "1",
                                "2"
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                        }
                    }
                ]
            }
        },
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                        "exact_snippets": "Written informed consent",
                        "criterion": "informed consent",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "criterion": "informed consent",
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                    }
                ]
            }
        },
        {
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                "line": "* Biopsy-proven newly diagnosed PCa;",
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                    {
                        "exact_snippets": "Biopsy-proven newly diagnosed PCa",
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                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "newly diagnosed"
                        }
                    },
                    {
                        "exact_snippets": "Biopsy-proven newly diagnosed PCa",
                        "criterion": "prostate cancer (PCa)",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy-proven"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
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                    },
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                            "expected_value": "biopsy-proven"
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                    }
                ]
            }
        },
        {
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                "line": "* International Society of Urological Pathology (ISUP) grade group (GG) ≥ 3 and/or PSA ≥ 20 ng/ml and/or ≥cT3a.",
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                        "criterion": "ISUP grade group",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
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                        }
                    },
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                                "operator": ">=",
                                "value": 20,
                                "unit": "ng/ml"
                            }
                        }
                    },
                    {
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                            "requirement_type": "stage",
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                    }
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                                                "value": 20,
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                                        "unit": "ng/ml"
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                    },
                    {
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "If all of the criteria above are met, a subject must also meet all of the following subgroup specific criteria:",
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                    {
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                        "criterion": "previous criteria",
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                            "expected_value": true
                        }
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                    "criterion": "subgroup specific criteria",
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                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
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                "line": "Group 1 (n=15):",
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                        }
                    },
                    {
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                        "criterion": "group assignment",
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                            "requirement_type": "sample size",
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                ]
            }
        },
        {
            "identified_line": {
                "line": "- PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or distant metastases.",
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                        "criterion": "PSMA-avid primary tumor",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
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                        "criterion": "PSMA-avid metastases",
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                        }
                    }
                ]
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                        ]
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                            "expected_value": true
                        }
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                    {
                        "exact_snippets": "no PSMA-avid loco-regional or distant metastases",
                        "criterion": "PSMA-avid loco-regional or distant metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
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                        "exact_snippets": "PSMA PET/CT with PSMA-avid primary tumor",
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                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no PSMA-avid loco-regional or distant metastases",
                        "criterion": "PSMA-avid loco-regional or distant metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti ≥40%) [22];",
                "criterions": [
                    {
                        "exact_snippets": "Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti ≥40%)",
                        "criterion": "risk of nodal metastases",
                        "requirement": {
                            "requirement_type": "risk assessment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti ≥40%)",
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                        "requirement": {
                            "requirement_type": "risk assessment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Scheduled for (laparoscopic) prostatectomy including ePLND.",
                "criterions": [
                    {
                        "exact_snippets": "Scheduled for (laparoscopic) prostatectomy",
                        "criterion": "prostatectomy",
                        "requirement": {
                            "requirement_type": "procedure",
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                        }
                    },
                    {
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                        "criterion": "ePLND",
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                            "requirement_type": "procedure",
                            "expected_value": "scheduled"
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Scheduled for (laparoscopic) prostatectomy",
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        },
        {
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                            "requirement_type": "status",
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        },
        {
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                        }
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        },
        {
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                            "requirement_type": "minimum",
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                                "unit": "Years"
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                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Known second malignant disease that may complicate image interpretation.",
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                        }
                    }
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                    }
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            }
        },
        {
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    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}