{
    "info": {
        "nct_id": "NCT06202820",
        "official_title": "CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients",
        "inclusion_criteria": "* Participants must have a histologic diagnosis of prostate adenocarcinoma. Participants with any stage of prostate cancer are eligible, as long as treatment with at least 24 weeks of ADT is recommended by their treating physician.\n* Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT, and can have received up to 12 weeks of ADT therapy.\n* Participants must be willing to participate in two CV CARE visits at weeks 12 and 24 after ADT initiation.\n* Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.\n* Participants must be willing to undergo lab and blood pressure assessments, which can include local labs and home blood pressure checks if they wish to do virtual visits for follow up care.\n* Participants can have pre-existing CVD and/or CV risk factors, but this is not a requirement for inclusion.\n* Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide), immunotherapy (pembrolizumab), or PARP inhibitor (olaparib, rucaparib) are eligible.\n* Age ≥18 years.\n* Life expectancy of greater than 6 months.\n* Ability to understand and the willingness to sign a written informed consent document.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 24 weeks due to complicated comorbidities that necessitate close collaboration between the participant and their cardiologist.\n* Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.\n* Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.\n* Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants must have a histologic diagnosis of prostate adenocarcinoma. Participants with any stage of prostate cancer are eligible, as long as treatment with at least 24 weeks of ADT is recommended by their treating physician.",
            "criterions": [
                {
                    "exact_snippets": "histologic diagnosis of prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any stage of prostate cancer",
                    "criterion": "stage of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with at least 24 weeks of ADT is recommended by their treating physician",
                    "criterion": "ADT treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT, and can have received up to 12 weeks of ADT therapy.",
            "criterions": [
                {
                    "exact_snippets": "Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT",
                    "criterion": "ADT treatment plan duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "can have received up to 12 weeks of ADT therapy",
                    "criterion": "prior ADT therapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must be willing to participate in two CV CARE visits at weeks 12 and 24 after ADT initiation.",
            "criterions": [
                {
                    "exact_snippets": "Participants must be willing to participate in two CV CARE visits",
                    "criterion": "willingness to participate in CV CARE visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at weeks 12 and 24 after ADT initiation",
                    "criterion": "timing of CV CARE visits",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "week 12",
                                "week 24"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.",
            "criterions": [
                {
                    "exact_snippets": "Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.",
                    "criterion": "willingness for follow-up visits at DFCI Longwood site",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must be willing to undergo lab and blood pressure assessments, which can include local labs and home blood pressure checks if they wish to do virtual visits for follow up care.",
            "criterions": [
                {
                    "exact_snippets": "Participants must be willing to undergo lab ... assessments",
                    "criterion": "willingness to undergo lab assessments",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants must be willing to undergo ... blood pressure assessments",
                    "criterion": "willingness to undergo blood pressure assessments",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants can have pre-existing CVD and/or CV risk factors, but this is not a requirement for inclusion.",
            "criterions": [
                {
                    "exact_snippets": "Participants can have pre-existing CVD",
                    "criterion": "pre-existing CVD",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants can have ... CV risk factors",
                    "criterion": "CV risk factors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide), immunotherapy (pembrolizumab), or PARP inhibitor (olaparib, rucaparib) are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide)",
                    "criterion": "androgen receptor signaling inhibitory treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants receiving combination treatment with ... immunotherapy (pembrolizumab)",
                    "criterion": "immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants receiving combination treatment with ... PARP inhibitor (olaparib, rucaparib)",
                    "criterion": "PARP inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of greater than 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than 6 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 24 weeks due to complicated comorbidities that necessitate close collaboration between the participant and their cardiologist.",
            "criterions": [
                {
                    "exact_snippets": "History of major adverse cardiac event, including myocardial infarction",
                    "criterion": "major adverse cardiac event",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "new congestive heart failure (CHF) or CHF exacerbation",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 24 weeks",
                    "criterion": "time since last major adverse cardiac event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 24,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "complicated comorbidities that necessitate close collaboration between the participant and their cardiologist",
                    "criterion": "complicated comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "necessity for collaboration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.",
            "criterions": [
                {
                    "exact_snippets": "Participants who have already been on ADT therapy for more than 12 weeks are ineligible",
                    "criterion": "ADT therapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ADT therapy is defined as either a GnRH agonist or antagonist",
                    "criterion": "ADT therapy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "GnRH agonist",
                                "GnRH antagonist"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.",
            "criterions": [
                {
                    "exact_snippets": "Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin)",
                    "criterion": "combination treatment with ADT and chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants receiving ... radioligand therapy (radium-223, 177PSMA-lutetium-617)",
                    "criterion": "radioligand therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants receiving ... treatment on a clinical trial",
                    "criterion": "treatment on a clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.",
            "criterions": [
                {
                    "exact_snippets": "Participants actively included in therapeutic clinical trials",
                    "criterion": "participation in therapeutic clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "actively included"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}