{
    "info": {
        "nct_id": "NCT03016741",
        "official_title": "Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer",
        "inclusion_criteria": "* Have diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy for at least 1 month prior to enrollment.\n* Willing and able to complete survey questionnaires in English without assistance through the duration of the study. This stipulation is in place because not all of the proposed quality of life or cognitive tests are available or validated in other languages.\n* Age ≥ 18 years.\n* Ability to understand and the willingness to sign a written informed consent document written in English that is approved by an institutional review board.\n* Have either newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC) or castration-resistant metastatic prostate cancer (mCRPC) and eligible to undergo treatment with abiraterone acetate (mHSPC or mCRPC) or enzalutamide (mCRPC)\n* Patients may have received the following prior AR directed therapy prior to enrollment: bicalutamide, ketoconazole. Prior to enrollment, patients may have received treatment with abiraterone acetate or enzalutamide for no more than 14 days before completing baseline studies.\n* Patients may have received chemotherapy for hormone-sensitive metastatic prostate cancer only, but it must not have lasted for more than 6 months. At least 12 months must have elapsed since completion of chemotherapy.\n* Patients may have received prior definitive radiation therapy or surgery. At least 60 days must have elapsed since completion of definitive radiation therapy or surgery and patient must have only grade 2 or less adverse effects at the time of registration. Enrollment during palliative radiation of ≤ 10 days, or radiation of ≤ 10 days during the duration of the study is allowed.\n* Patients must be able to take oral medication.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment with enzalutamide or abiraterone acetate for > 14 days prior to enrollment and completion of baseline tests.\n* Receipt of chemotherapy for prostate or other cancer within the past 12 months with residual cognitive deficits, or receipt of chemotherapy for mCRPC. Patients/physicians planning treatment with chemotherapy during the 12 month period of the investigation are also ineligible.\n* History of cognitive impairment or dysfunction, including a history of dementia, Alzheimer's disease, stroke with residual cognitive deficits, cognitive dysfunction related to alcohol or substance abuse, or cognitive dysfunction related to prior treatment for any cancer.\n* Patients with a seizure history, history of recurrent falls, or known brain metastases are excluded from this clinical trial because of their poor prognosis and because of their heightened risk of seizure or progressive cognitive and/or neurologic dysfunction that would confound the evaluation.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations/substance abuse that would limit compliance with study requirements.\n* Patients with a \"currently active\" second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a \"currently active\" malignancy if they have completed all therapy and are now considered without evidence of disease for 1 year. Patients with cognitive dysfunction related to treatment of another malignancy, including a history of \"chemo-brain\", are ineligible.\n* Patients taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior. Appropriate treatment by a licensed provider with medications for depression or anxiety, including but not limited to SSRIs, SNRIs, and standard dose benzodiazepines at a stable dose, is permitted",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy for at least 1 month prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "diagnosis of prostate cancer"
                    ],
                    "criterion": "prostate cancer",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "received treatment with GnRH agonist or antagonist therapy"
                    ],
                    "criterion": "GnRH agonist or antagonist therapy",
                    "requirement_type": "treatment history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "at least 1 month prior to enrollment"
                    ],
                    "criterion": "GnRH agonist or antagonist therapy",
                    "requirement_type": "treatment duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Willing and able to complete survey questionnaires in English without assistance through the duration of the study. This stipulation is in place because not all of the proposed quality of life or cognitive tests are available or validated in other languages.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Willing",
                        "to complete survey questionnaires"
                    ],
                    "criterion": "survey questionnaires",
                    "requirement_type": "willingness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "able to complete survey questionnaires in English without assistance"
                    ],
                    "criterion": "survey questionnaires",
                    "requirement_type": "ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "complete survey questionnaires in English"
                    ],
                    "criterion": "language",
                    "requirement_type": "requirement",
                    "expected_value": "English"
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age ≥ 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "N/A",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document written in English that is approved by an institutional review board.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Ability to understand"
                    ],
                    "criterion": "understanding",
                    "requirement_type": "ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "willingness to sign a written informed consent document"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "willingness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "written in English"
                    ],
                    "criterion": "language of consent document",
                    "requirement_type": "language",
                    "expected_value": "English"
                },
                {
                    "exact_snippets": [
                        "approved by an institutional review board"
                    ],
                    "criterion": "IRB approval",
                    "requirement_type": "approval",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Have either newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC) or castration-resistant metastatic prostate cancer (mCRPC) and eligible to undergo treatment with abiraterone acetate (mHSPC or mCRPC) or enzalutamide (mCRPC)",
            "criterions": [
                {
                    "exact_snippets": [
                        "newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC)"
                    ],
                    "criterion": "metastatic hormone sensitive prostate cancer",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "castration-resistant metastatic prostate cancer (mCRPC)"
                    ],
                    "criterion": "castration-resistant metastatic prostate cancer",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "eligible to undergo treatment with abiraterone acetate (mHSPC or mCRPC)"
                    ],
                    "criterion": "treatment with abiraterone acetate",
                    "requirement_type": "eligibility",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "eligible to undergo treatment with",
                        "enzalutamide (mCRPC)"
                    ],
                    "criterion": "treatment with enzalutamide",
                    "requirement_type": "eligibility",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients may have received the following prior AR directed therapy prior to enrollment: bicalutamide, ketoconazole. Prior to enrollment, patients may have received treatment with abiraterone acetate or enzalutamide for no more than 14 days before completing baseline studies.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients may have received the following prior AR directed therapy",
                        "bicalutamide"
                    ],
                    "criterion": "prior AR directed therapy",
                    "requirement_type": "receipt",
                    "expected_value": "bicalutamide"
                },
                {
                    "exact_snippets": [
                        "Patients may have received the following prior AR directed therapy",
                        "ketoconazole"
                    ],
                    "criterion": "prior AR directed therapy",
                    "requirement_type": "receipt",
                    "expected_value": "ketoconazole"
                },
                {
                    "exact_snippets": [
                        "Prior to enrollment, patients may have received treatment with abiraterone acetate",
                        "for no more than 14 days"
                    ],
                    "criterion": "abiraterone acetate treatment duration",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 14
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Prior to enrollment, patients may have received treatment with",
                        "enzalutamide",
                        "for no more than 14 days"
                    ],
                    "criterion": "enzalutamide treatment duration",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 14
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients may have received chemotherapy for hormone-sensitive metastatic prostate cancer only, but it must not have lasted for more than 6 months. At least 12 months must have elapsed since completion of chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients may have received chemotherapy for hormone-sensitive metastatic prostate cancer"
                    ],
                    "criterion": "chemotherapy for hormone-sensitive metastatic prostate cancer",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "it must not have lasted for more than 6 months"
                    ],
                    "criterion": "chemotherapy duration",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": "<=",
                        "value": 6
                    }
                },
                {
                    "exact_snippets": [
                        "At least 12 months must have elapsed since completion of chemotherapy"
                    ],
                    "criterion": "time since chemotherapy completion",
                    "requirement_type": "elapsed time",
                    "expected_value": {
                        "operator": ">=",
                        "value": 12
                    }
                }
            ]
        },
        {
            "line": "* Patients may have received prior definitive radiation therapy or surgery. At least 60 days must have elapsed since completion of definitive radiation therapy or surgery and patient must have only grade 2 or less adverse effects at the time of registration. Enrollment during palliative radiation of ≤ 10 days, or radiation of ≤ 10 days during the duration of the study is allowed.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients may have received prior definitive radiation therapy"
                    ],
                    "criterion": "prior definitive radiation therapy",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients may have received prior definitive",
                        "surgery"
                    ],
                    "criterion": "prior definitive surgery",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "At least 60 days must have elapsed since completion of definitive radiation therapy or surgery"
                    ],
                    "criterion": "time since completion of definitive radiation therapy or surgery",
                    "requirement_type": "elapsed time",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 60
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "patient must have only grade 2 or less adverse effects at the time of registration"
                    ],
                    "criterion": "adverse effects",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Enrollment during palliative radiation of ≤ 10 days"
                    ],
                    "criterion": "palliative radiation duration",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "radiation of ≤ 10 days during the duration of the study is allowed"
                    ],
                    "criterion": "radiation duration during study",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients must be able to take oral medication.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must be able to take oral medication"
                    ],
                    "criterion": "oral medication",
                    "requirement_type": "ability to take",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be MALE"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific value",
                    "expected_value": "male"
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior treatment with enzalutamide or abiraterone acetate for > 14 days prior to enrollment and completion of baseline tests.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior treatment with enzalutamide"
                    ],
                    "criterion": "enzalutamide treatment",
                    "requirement_type": "prior duration",
                    "expected_value": {
                        "operator": ">",
                        "value": 14
                    }
                },
                {
                    "exact_snippets": [
                        "Prior treatment with",
                        "abiraterone acetate"
                    ],
                    "criterion": "abiraterone acetate treatment",
                    "requirement_type": "prior duration",
                    "expected_value": {
                        "operator": ">",
                        "value": 14
                    }
                },
                {
                    "exact_snippets": [
                        "completion of baseline tests"
                    ],
                    "criterion": "baseline tests",
                    "requirement_type": "completion",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Receipt of chemotherapy for prostate or other cancer within the past 12 months with residual cognitive deficits, or receipt of chemotherapy for mCRPC. Patients/physicians planning treatment with chemotherapy during the 12 month period of the investigation are also ineligible.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Receipt of chemotherapy for prostate or other cancer within the past 12 months"
                    ],
                    "criterion": "chemotherapy receipt",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 12
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "residual cognitive deficits"
                    ],
                    "criterion": "cognitive deficits",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "receipt of chemotherapy for mCRPC"
                    ],
                    "criterion": "chemotherapy receipt",
                    "requirement_type": "condition",
                    "expected_value": "mCRPC"
                },
                {
                    "exact_snippets": [
                        "Patients/physicians planning treatment with chemotherapy during the 12 month period of the investigation"
                    ],
                    "criterion": "chemotherapy treatment planning",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 12
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* History of cognitive impairment or dysfunction, including a history of dementia, Alzheimer's disease, stroke with residual cognitive deficits, cognitive dysfunction related to alcohol or substance abuse, or cognitive dysfunction related to prior treatment for any cancer.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of cognitive impairment or dysfunction"
                    ],
                    "criterion": "cognitive impairment or dysfunction",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "history of dementia"
                    ],
                    "criterion": "dementia",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Alzheimer's disease"
                    ],
                    "criterion": "Alzheimer's disease",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "stroke with residual cognitive deficits"
                    ],
                    "criterion": "stroke with residual cognitive deficits",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "cognitive dysfunction related to alcohol or substance abuse"
                    ],
                    "criterion": "cognitive dysfunction related to alcohol or substance abuse",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "cognitive dysfunction related to prior treatment for any cancer"
                    ],
                    "criterion": "cognitive dysfunction related to prior treatment for any cancer",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with a seizure history, history of recurrent falls, or known brain metastases are excluded from this clinical trial because of their poor prognosis and because of their heightened risk of seizure or progressive cognitive and/or neurologic dysfunction that would confound the evaluation.",
            "criterions": [
                {
                    "exact_snippets": [
                        "seizure history"
                    ],
                    "criterion": "seizure history",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "history of recurrent falls"
                    ],
                    "criterion": "recurrent falls",
                    "requirement_type": "history",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "known brain metastases"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations/substance abuse that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Uncontrolled intercurrent illness"
                    ],
                    "criterion": "intercurrent illness",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "uncontrolled diabetes"
                    ],
                    "criterion": "diabetes",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "ongoing or active infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "symptomatic congestive heart failure",
                        "New York Heart Association Class III and IV heart failure"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "severity",
                    "expected_value": [
                        "symptomatic",
                        "New York Heart Association Class III and IV"
                    ]
                },
                {
                    "exact_snippets": [
                        "unstable angina pectoris"
                    ],
                    "criterion": "angina pectoris",
                    "requirement_type": "stability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "cardiac arrhythmia"
                    ],
                    "criterion": "cardiac arrhythmia",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "psychiatric illness/social situations/substance abuse that would limit compliance with study requirements"
                    ],
                    "criterion": "psychiatric illness/social situations/substance abuse",
                    "requirement_type": "impact on compliance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior. Appropriate treatment by a licensed provider with medications for depression or anxiety, including but not limited to SSRIs, SNRIs, and standard dose benzodiazepines at a stable dose, is permitted",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients taking psychotropic medications"
                    ],
                    "criterion": "psychotropic medications",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "illicit drugs that may alter cognition, concentration, or behavior"
                    ],
                    "criterion": "illicit drugs",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Appropriate treatment by a licensed provider with medications for depression or anxiety"
                    ],
                    "criterion": "treatment for depression or anxiety",
                    "requirement_type": "appropriateness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "SSRIs, SNRIs, and standard dose benzodiazepines at a stable dose"
                    ],
                    "criterion": "medications",
                    "requirement_type": "stability",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients with a \"currently active\" second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a \"currently active\" malignancy if they have completed all therapy and are now considered without evidence of disease for 1 year. Patients with cognitive dysfunction related to treatment of another malignancy, including a history of \"chemo-brain\", are ineligible.",
            "criterions": [
                {
                    "exact_snippets": [
                        "currently active second malignancy other than non-melanoma skin cancers"
                    ],
                    "criterion": "second malignancy",
                    "requirement_type": "activity status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "completed all therapy",
                        "without evidence of disease for 1 year"
                    ],
                    "criterion": "malignancy",
                    "requirement_type": "disease status",
                    "expected_value": "without evidence of disease for 1 year"
                },
                {
                    "exact_snippets": [
                        "cognitive dysfunction related to treatment of another malignancy"
                    ],
                    "criterion": "cognitive dysfunction",
                    "requirement_type": "relation to treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "history of \"chemo-brain\""
                    ],
                    "criterion": "chemo-brain",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}