{
    "info": {
        "nct_id": "NCT01993160",
        "official_title": "18F-FCH-PET/MR in Staging of High-Risk Prostate Cancer: A Multiparametric Approach",
        "inclusion_criteria": "* Age ≥ 18 years\n* Histologic diagnosis of carcinoma of prostate\n* High risk disease: defined as Gleason ≥8, or T3 disease, or PSA >20ng/mL\n* No prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy).\n* Ability to provide written informed consent to participate in the study\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Prior surgery or radiation therapy for prostate cancer\n* Prior or ongoing hormone or other systemic therapy for prostate cancer\n* Inability to lie supine for 90 minutes\n* Any contraindication to MR as per Joint Department of Medical Imaging policies.\n* Impaired kidney function with glomerular filtration rate < 30ml/min\n* Previous anaphylactic reaction to gadolinium or other contraindications to MR.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic diagnosis of carcinoma of prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologic diagnosis of carcinoma of prostate",
                    "criterion": "carcinoma of prostate",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High risk disease: defined as Gleason ≥8, or T3 disease, or PSA >20ng/mL",
            "criterions": [
                {
                    "exact_snippets": "Gleason ≥8",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "T3 disease",
                    "criterion": "T stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T3"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA >20ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy).",
            "criterions": [
                {
                    "exact_snippets": "No prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy)",
                    "criterion": "prior therapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to provide written informed consent to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "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 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 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior surgery or radiation therapy for prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior surgery ... for prostate cancer",
                    "criterion": "surgery for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... radiation therapy for prostate cancer",
                    "criterion": "radiation therapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior or ongoing hormone or other systemic therapy for prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior or ongoing hormone or other systemic therapy for prostate cancer",
                    "criterion": "systemic therapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "prior",
                                "ongoing"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior or ongoing hormone or other systemic therapy for prostate cancer",
                    "criterion": "hormone therapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "prior",
                                "ongoing"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to lie supine for 90 minutes",
            "criterions": [
                {
                    "exact_snippets": "Inability to lie supine for 90 minutes",
                    "criterion": "ability to lie supine",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "minutes"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any contraindication to MR as per Joint Department of Medical Imaging policies.",
            "criterions": [
                {
                    "exact_snippets": "Any contraindication to MR",
                    "criterion": "contraindication to MR",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Impaired kidney function with glomerular filtration rate < 30ml/min",
            "criterions": [
                {
                    "exact_snippets": "Impaired kidney function with glomerular filtration rate < 30ml/min",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "glomerular filtration rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous anaphylactic reaction to gadolinium or other contraindications to MR.",
            "criterions": [
                {
                    "exact_snippets": "Previous anaphylactic reaction to gadolinium",
                    "criterion": "anaphylactic reaction to gadolinium",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other contraindications to MR",
                    "criterion": "contraindications to MR",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}