{
    "info": {
        "nct_id": "NCT05612880",
        "official_title": "Assessing Physical Function Following Androgen Receptor Signaling Inhibitor Treatment for Metastatic Prostate Cancer",
        "inclusion_criteria": "* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.\n* Age ≥ 18 years at the time of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Diagnosis of metastatic disease from prostate cancer, or recurrent disease following definitive local therapy of prostate cancer, as assessed by their clinician\n* Initiation of an ARSI (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide) for mPC with concurrent androgen deprivation therapy (ADT).\n* Availability to begin baseline testing within 8 weeks of ARSI treatment initiation.\n* Physician clearance to perform physical assessments.\n* Ability to speak and read English.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior ARSI treatment\n* Current chemotherapy\n* History of bone fractures or musculoskeletal injuries\n* Neurological conditions that affect balance and/or muscle strength\n* Intention to leave the region prior to completion of study\n* Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIPAA authorization for release of personal health information",
                    "criterion": "HIPAA authorization",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.",
            "criterions": [
                {
                    "exact_snippets": "Subjects is willing",
                    "criterion": "willingness to comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to comply with study procedures",
                    "criterion": "ability to comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years at the time of consent.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of metastatic disease from prostate cancer, or recurrent disease following definitive local therapy of prostate cancer, as assessed by their clinician",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of metastatic disease from prostate cancer",
                    "criterion": "metastatic disease from prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent disease following definitive local therapy of prostate cancer",
                    "criterion": "recurrent disease following definitive local therapy of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Initiation of an ARSI (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide) for mPC with concurrent androgen deprivation therapy (ADT).",
            "criterions": [
                {
                    "exact_snippets": "Initiation of an ARSI (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide)",
                    "criterion": "ARSI initiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mPC",
                    "criterion": "metastatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrent androgen deprivation therapy (ADT)",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Availability to begin baseline testing within 8 weeks of ARSI treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Availability to begin baseline testing within 8 weeks of ARSI treatment initiation.",
                    "criterion": "baseline testing availability",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Physician clearance to perform physical assessments.",
            "criterions": [
                {
                    "exact_snippets": "Physician clearance to perform physical assessments.",
                    "criterion": "physician clearance",
                    "requirements": [
                        {
                            "requirement_type": "authorization",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to speak and read English.",
            "criterions": [
                {
                    "exact_snippets": "Ability to speak ... English.",
                    "criterion": "language ability",
                    "requirements": [
                        {
                            "requirement_type": "speak",
                            "expected_value": "English"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ability to ... read English.",
                    "criterion": "language ability",
                    "requirements": [
                        {
                            "requirement_type": "read",
                            "expected_value": "English"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior ARSI treatment",
            "criterions": [
                {
                    "exact_snippets": "Prior ARSI treatment",
                    "criterion": "ARSI treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Current chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "current",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of bone fractures or musculoskeletal injuries",
            "criterions": [
                {
                    "exact_snippets": "History of bone fractures",
                    "criterion": "bone fractures",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... musculoskeletal injuries",
                    "criterion": "musculoskeletal injuries",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neurological conditions that affect balance and/or muscle strength",
            "criterions": [
                {
                    "exact_snippets": "Neurological conditions that affect balance",
                    "criterion": "neurological conditions affecting balance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Neurological conditions that affect ... muscle strength",
                    "criterion": "neurological conditions affecting muscle strength",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intention to leave the region prior to completion of study",
            "criterions": [
                {
                    "exact_snippets": "Intention to leave the region",
                    "criterion": "intention to leave the region",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent",
            "criterions": [
                {
                    "exact_snippets": "Dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "altered mental status",
                    "criterion": "altered mental status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any psychiatric condition prohibiting the understanding or rendering of informed consent",
                    "criterion": "psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on informed consent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}