{
    "info": {
        "nct_id": "NCT04928820",
        "official_title": "Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT With 99mTc-MDP Bone Scan and CT for Detection of M1b Disease in Prostate Cancer Patients With Biochemical Progression During ADT",
        "inclusion_criteria": "* Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen [PSA] level >= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)\n* Patients with bone scan scheduled or performed\n\n  * Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between\n  * Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized\n* Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility\n* Patients or their legal representatives must have the ability to read, understand and provide written informed consent\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Initiation of a new therapy between the PSMA PET/CT and the bone scans\n* Inability to provide written informed consent\n* Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with bone scan scheduled or performed",
            "criterions": [
                {
                    "exact_snippets": "bone scan scheduled or performed",
                    "criterion": "bone scan",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "scheduled",
                                "performed"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between",
            "criterions": [
                {
                    "exact_snippets": "Within 30 days of the PSMA PET",
                    "criterion": "time since PSMA PET",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without any new prostate cancer (PCa) therapy in between",
                    "criterion": "new prostate cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility",
            "criterions": [
                {
                    "exact_snippets": "Patients enrolled in other clinical trials",
                    "criterion": "enrollment in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients or their legal representatives must have the ability to read, understand and provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients or their legal representatives must have the ability to read, understand and provide written informed consent",
                    "criterion": "ability to provide 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": "Must be 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Initiation of a new therapy between the PSMA PET/CT and the bone scans",
            "criterions": [
                {
                    "exact_snippets": "Initiation of a new therapy between the PSMA PET/CT and the bone scans",
                    "criterion": "new therapy initiation",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "between the PSMA PET/CT and the bone scans"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Inability to provide written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)",
            "criterions": [
                {
                    "exact_snippets": "Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)",
                    "criterion": "ability to remain still and lie flat",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen [PSA] level >= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)",
            "criterions": [
                {
                    "exact_snippets": "biochemical progression during ADT or combination therapies including ADT",
                    "criterion": "biochemical progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "referred for imaging evaluation",
                    "criterion": "referral for imaging evaluation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate specific antigen [PSA] level >= 1 ng/ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "increased on at least 2 successive occasions at least 1 week apart",
                    "criterion": "PSA level increase",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "at least 2 successive occasions"
                        },
                        {
                            "requirement_type": "time interval",
                            "expected_value": "at least 1 week apart"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized",
            "criterions": [
                {
                    "exact_snippets": "Bone scans performed at University of California, Los Angeles (UCLA)",
                    "criterion": "bone scan location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "University of California, Los Angeles (UCLA)"
                        }
                    ]
                },
                {
                    "exact_snippets": "Bone scans performed at ... external institutions",
                    "criterion": "bone scan location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "external institutions"
                        }
                    ]
                },
                {
                    "exact_snippets": "DICOM images can be obtained",
                    "criterion": "DICOM image availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "DICOM images can be ... imported",
                    "criterion": "DICOM image importability",
                    "requirements": [
                        {
                            "requirement_type": "importability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "DICOM images can be ... anonymized",
                    "criterion": "DICOM image anonymization",
                    "requirements": [
                        {
                            "requirement_type": "anonymization",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}