{
    "info": {
        "nct_id": "NCT06675357",
        "official_title": "Novel FAP-targeted Approach to Metastatic Prostate Cancer",
        "inclusion_criteria": "* Age 18 years or older\n* Able and willing to provide informed consent\n* Known diagnosis of prostate cancer with established or suspected non-osseous, non-nodal metastases\n* Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET\n* Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.\n* Willing and able to undergo PET/MRI as part of this research\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Unable or unwilling to provide informed consent\n* Contraindication(s) to or inability to undergo PET/MRI\n* Participants for whom PET/MRI will delay timely delivery of treatment\n* Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:\n* Have their own prescription for the medication\n* The informed consent process is conducted prior to the self-administration of this medication\n* Come to the research visit with a driver",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able and willing to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able ... to provide informed consent",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to provide informed consent",
                    "criterion": "willingness to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known diagnosis of prostate cancer with established or suspected non-osseous, non-nodal metastases",
            "criterions": [
                {
                    "exact_snippets": "Known diagnosis of prostate cancer",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "established or suspected non-osseous, non-nodal metastases",
                    "criterion": "non-osseous, non-nodal metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "established",
                                "suspected"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET",
            "criterions": [
                {
                    "exact_snippets": "Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET",
                    "criterion": "PSMA PET",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "scheduled",
                                "recently performed"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.",
            "criterions": [
                {
                    "exact_snippets": "Scheduled for SOC biopsy",
                    "criterion": "SOC biopsy",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "established or suspected non-osseous, non-nodal metastases",
                    "criterion": "non-osseous, non-nodal metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "established",
                                "suspected"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to undergo PET/MRI as part of this research",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to undergo PET/MRI",
                    "criterion": "PET/MRI",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "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 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Unable or unwilling to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Unable ... to provide informed consent",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to provide informed consent",
                    "criterion": "willingness to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication(s) to or inability to undergo PET/MRI",
            "criterions": [
                {
                    "exact_snippets": "Contraindication(s) to ... undergo PET/MRI",
                    "criterion": "PET/MRI",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to undergo PET/MRI",
                    "criterion": "PET/MRI",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants for whom PET/MRI will delay timely delivery of treatment",
            "criterions": [
                {
                    "exact_snippets": "Participants for whom PET/MRI will delay timely delivery of treatment",
                    "criterion": "PET/MRI delay",
                    "requirements": [
                        {
                            "requirement_type": "impact on treatment",
                            "expected_value": "delay"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:",
            "criterions": [
                {
                    "exact_snippets": "requiring intravenous (IV) conscious sedation for imaging care",
                    "criterion": "IV conscious sedation requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring mild, oral anxiolytics for the clinical MRI",
                    "criterion": "oral anxiolytics requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have their own prescription for the medication",
            "criterions": [
                {
                    "exact_snippets": "Have their own prescription for the medication",
                    "criterion": "prescription for the medication",
                    "requirements": [
                        {
                            "requirement_type": "ownership",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The informed consent process is conducted prior to the self-administration of this medication",
            "criterions": [
                {
                    "exact_snippets": "The informed consent process is conducted prior to the self-administration of this medication",
                    "criterion": "informed consent process",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to self-administration of medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Come to the research visit with a driver",
            "criterions": [
                {
                    "exact_snippets": "Come to the research visit with a driver",
                    "criterion": "driver accompaniment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}