{
    "info": {
        "nct_id": "NCT02659527",
        "official_title": "Randomized Assessment of Patients With Clinically Suspected Prostate Cancer After Multiparametric Metabolic Hybrid Imaging to Evaluate Its Potential Clinical Domain: A Prospective, Randomized, Multi-arm, Multi-treatment Clinical Trial",
        "inclusion_criteria": "* blood PSA level > 4.0 ng/ml and\n* free-to-total PSA ratio <22% and/or\n* progressive rise of PSA levels in two consecutive blood samples despite antibiotics\nHealthy volunteers allowed\nMust be MALE",
        "exclusion_criteria": "* antiandrogen therapy\n* prostate needle biopsy <21 days before PET/MRI\n* known active secondary cancer\n* endorectal coil not applicable (e.g. anus praetor with short rectal stump)\n* known active prostatitis (e.g. painful DRE)\n* known anaphylaxis against gadolinium-DOTA\n* patient's written informed consent not given\n* needle biopsy and/or prostatectomy compound not available for histology/immunohistochemistry",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* blood PSA level > 4.0 ng/ml and",
            "criterions": [
                {
                    "exact_snippets": "blood PSA level > 4.0 ng/ml",
                    "criterion": "blood PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 4.0,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* free-to-total PSA ratio <22% and/or",
            "criterions": [
                {
                    "exact_snippets": "free-to-total PSA ratio <22%",
                    "criterion": "free-to-total PSA ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 22,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* progressive rise of PSA levels in two consecutive blood samples despite antibiotics",
            "criterions": [
                {
                    "exact_snippets": "progressive rise of PSA levels",
                    "criterion": "PSA levels",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "progressive rise"
                        }
                    ]
                },
                {
                    "exact_snippets": "two consecutive blood samples",
                    "criterion": "blood samples",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 2"
                        }
                    ]
                },
                {
                    "exact_snippets": "despite antibiotics",
                    "criterion": "antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* antiandrogen therapy",
            "criterions": [
                {
                    "exact_snippets": "antiandrogen therapy",
                    "criterion": "antiandrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prostate needle biopsy <21 days before PET/MRI",
            "criterions": [
                {
                    "exact_snippets": "prostate needle biopsy <21 days before PET/MRI",
                    "criterion": "prostate needle biopsy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* known active secondary cancer",
            "criterions": [
                {
                    "exact_snippets": "known active secondary cancer",
                    "criterion": "secondary cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* endorectal coil not applicable (e.g. anus praetor with short rectal stump)",
            "criterions": [
                {
                    "exact_snippets": "endorectal coil not applicable",
                    "criterion": "endorectal coil",
                    "requirements": [
                        {
                            "requirement_type": "applicability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anus praetor with short rectal stump",
                    "criterion": "anus praetor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anus praetor with short rectal stump",
                    "criterion": "short rectal stump",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* known active prostatitis (e.g. painful DRE)",
            "criterions": [
                {
                    "exact_snippets": "known active prostatitis",
                    "criterion": "active prostatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "painful DRE",
                    "criterion": "painful DRE",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* known anaphylaxis against gadolinium-DOTA",
            "criterions": [
                {
                    "exact_snippets": "known anaphylaxis against gadolinium-DOTA",
                    "criterion": "anaphylaxis against gadolinium-DOTA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient's written informed consent not given",
            "criterions": [
                {
                    "exact_snippets": "patient's written informed consent not given",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* needle biopsy and/or prostatectomy compound not available for histology/immunohistochemistry",
            "criterions": [
                {
                    "exact_snippets": "needle biopsy and/or prostatectomy compound not available for histology/immunohistochemistry",
                    "criterion": "needle biopsy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "needle biopsy and/or prostatectomy compound not available for histology/immunohistochemistry",
                    "criterion": "prostatectomy compound",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}