{
    "info": {
        "nct_id": "NCT02364531",
        "official_title": "A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting. The COSMiC Prospective Prostate Cancer Registry",
        "inclusion_criteria": "* Participants must have a confirmed diagnosis of metastatic castrate-resistant prostate cancer (mCRPC) according to medical history and have rising Prostate-Specific Antigen (PSA) levels or radiographic progression (documented by previous positive bone scan or metastatic lesions identified on CT or MRI) despite ongoing conventional Androgen deprivation therapy (ADT)\n* Participant (or legally accepted representative) must be able to sign an informed consent form (ICF) indicating that they understand the procedures for data collection and are willing to participate in the study\n* Participant must be able to understand and complete study questionnaires\n* Abiraterone Acetate (ZYTIGA) has been chosen as the treatment for mCRPC disease progression as part of standard of care\n* Male participants aged greater than (>) 18 years\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participants currently participating in another investigational clinical study of ZYTIGA or any other investigational drug\n* Participants who have received prior cytotoxic chemotherapy for prostate cancer while receiving ADT\n* Participants who have any other condition that, in the opinion of the investigator, may affect the participants health or outcome of the trial (i.e. uncontrolled disease)\n* Life expectancy of less than (<) 1 year\n* History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants must have a confirmed diagnosis of metastatic castrate-resistant prostate cancer (mCRPC) according to medical history and have rising Prostate-Specific Antigen (PSA) levels or radiographic progression (documented by previous positive bone scan or metastatic lesions identified on CT or MRI) despite ongoing conventional Androgen deprivation therapy (ADT)",
            "criterions": [
                {
                    "exact_snippets": "confirmed diagnosis of metastatic castrate-resistant prostate cancer (mCRPC)",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "metastatic castrate-resistant prostate cancer (mCRPC)"
                        }
                    ]
                },
                {
                    "exact_snippets": "rising Prostate-Specific Antigen (PSA) levels",
                    "criterion": "Prostate-Specific Antigen (PSA) levels",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        }
                    ]
                },
                {
                    "exact_snippets": "radiographic progression (documented by previous positive bone scan or metastatic lesions identified on CT or MRI)",
                    "criterion": "radiographic progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "previous positive bone scan",
                                "metastatic lesions identified on CT",
                                "metastatic lesions identified on MRI"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing conventional Androgen deprivation therapy (ADT)",
                    "criterion": "Androgen deprivation therapy (ADT)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant (or legally accepted representative) must be able to sign an informed consent form (ICF) indicating that they understand the procedures for data collection and are willing to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Participant (or legally accepted representative) must be able to sign an informed consent form (ICF)",
                    "criterion": "ability to sign informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that they understand the procedures for data collection",
                    "criterion": "understanding of data collection procedures",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to participate in the study",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant must be able to understand and complete study questionnaires",
            "criterions": [
                {
                    "exact_snippets": "Participant must be able to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complete study questionnaires",
                    "criterion": "ability to complete questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abiraterone Acetate (ZYTIGA) has been chosen as the treatment for mCRPC disease progression as part of standard of care",
            "criterions": [
                {
                    "exact_snippets": "Abiraterone Acetate (ZYTIGA) has been chosen as the treatment",
                    "criterion": "treatment choice",
                    "requirements": [
                        {
                            "requirement_type": "expected treatment",
                            "expected_value": "Abiraterone Acetate (ZYTIGA)"
                        }
                    ]
                },
                {
                    "exact_snippets": "mCRPC disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "mCRPC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male participants aged greater than (>) 18 years",
            "criterions": [
                {
                    "exact_snippets": "Male participants",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged greater than (>) 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Participants currently participating in another investigational clinical study of ZYTIGA or any other investigational drug",
            "criterions": [
                {
                    "exact_snippets": "Participants currently participating in another investigational clinical study of ZYTIGA",
                    "criterion": "participation in investigational clinical study of ZYTIGA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants currently participating in ... any other investigational drug",
                    "criterion": "participation in investigational clinical study of any other investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who have received prior cytotoxic chemotherapy for prostate cancer while receiving ADT",
            "criterions": [
                {
                    "exact_snippets": "Participants who have received prior cytotoxic chemotherapy for prostate cancer",
                    "criterion": "prior cytotoxic chemotherapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while receiving ADT",
                    "criterion": "ADT",
                    "requirements": [
                        {
                            "requirement_type": "concurrent treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who have any other condition that, in the opinion of the investigator, may affect the participants health or outcome of the trial (i.e. uncontrolled disease)",
            "criterions": [
                {
                    "exact_snippets": "any other condition ... may affect the participants health or outcome of the trial",
                    "criterion": "other condition",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "may affect health or outcome of the trial"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled disease",
                    "criterion": "disease control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of less than (<) 1 year",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of less than (<) 1 year",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "History of another malignancy within the previous 5 years",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other than curatively treated non-melanoma skin cancer",
                    "criterion": "curatively treated non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}