{
    "info": {
        "nct_id": "NCT05850182",
        "official_title": "A Pilot Study to Investigate the Effects of Lifestyle Intervention on Physical Activity and Diet in Patients With Metastatic Prostate Cancer Receiving Novel Hormonal Agents: the ACTIDIET-PRO Study",
        "inclusion_criteria": "* Written informed consent according to ICH/GCP regulations before registration.\n* Age ≥ 18 years\n* Histology of adenocarcinoma of the prostate\n* Patients with PCa receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)\n* Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation\n* PSA doubling time > 8 weeks\n* Continuation of ongoing systemic treatment is deemed feasible by treating physician\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments\n* Evidence of clinical progression or progression of disease on imaging\n* Bone metastases excluding the safety of physical exercise\n* Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures\n* Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening; uncontrolled angina within 3 months before screening; congestive heart failure New York Heart Association class 3 or 4; history of clinically significant arrhythmias; uncontrolled hypertension indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening)\n* Clinically significant chronic obstructive pulmonary disease\n* Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Written informed consent according to ICH/GCP regulations before registration.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent according to ICH/GCP regulations",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": "ICH/GCP regulations"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histology of adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histology of adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "histology",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with PCa receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)",
            "criterions": [
                {
                    "exact_snippets": "Patients with PCa",
                    "criterion": "prostate cancer (PCa)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)",
                    "criterion": "androgen deprivation therapy (ADT)",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "ADT alone",
                                "ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation",
            "criterions": [
                {
                    "exact_snippets": "Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart)",
                    "criterion": "PSA levels",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        },
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "% above nadir"
                            }
                        },
                        {
                            "requirement_type": "time interval",
                            "expected_value": "at least three weeks apart"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of clinical or radiographic progression on instrumental evaluation",
                    "criterion": "clinical or radiographic progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA doubling time > 8 weeks",
            "criterions": [
                {
                    "exact_snippets": "PSA doubling time > 8 weeks",
                    "criterion": "PSA doubling time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Continuation of ongoing systemic treatment is deemed feasible by treating physician",
            "criterions": [
                {
                    "exact_snippets": "Continuation of ongoing systemic treatment is deemed feasible by treating physician",
                    "criterion": "systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "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": "* Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments",
            "criterions": [
                {
                    "exact_snippets": "Ongoing treatment with docetaxel",
                    "criterion": "ongoing treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "docetaxel"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ongoing treatment with ... cabazitaxel",
                    "criterion": "ongoing treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "cabazitaxel"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ongoing treatment with ... radionuclides",
                    "criterion": "ongoing treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "radionuclides"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ongoing treatment with ... investigational treatments",
                    "criterion": "ongoing treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "investigational treatments"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of clinical progression or progression of disease on imaging",
            "criterions": [
                {
                    "exact_snippets": "Evidence of clinical progression",
                    "criterion": "clinical progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progression of disease on imaging",
                    "criterion": "disease progression on imaging",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone metastases excluding the safety of physical exercise",
            "criterions": [
                {
                    "exact_snippets": "Bone metastases",
                    "criterion": "bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding the safety of physical exercise",
                    "criterion": "safety of physical exercise",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures",
            "criterions": [
                {
                    "exact_snippets": "Prior confirmed severe osteoporosis",
                    "criterion": "osteoporosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other diseases affecting the bone",
                    "criterion": "diseases affecting the bone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of fractures",
                    "criterion": "fractures",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening; uncontrolled angina within 3 months before screening; congestive heart failure New York Heart Association class 3 or 4; history of clinically significant arrhythmias; uncontrolled hypertension indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening)",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant cardiovascular disease ... uncontrolled angina within 3 months before screening",
                    "criterion": "uncontrolled angina",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant cardiovascular disease ... congestive heart failure New York Heart Association class 3 or 4",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "New York Heart Association class 3",
                                "New York Heart Association class 4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant cardiovascular disease ... history of clinically significant arrhythmias",
                    "criterion": "clinically significant arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant cardiovascular disease ... uncontrolled hypertension indicated by systolic blood pressure > 170 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 170,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant cardiovascular disease ... uncontrolled hypertension indicated by ... diastolic blood pressure > 105 mm Hg at screening",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 105,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant chronic obstructive pulmonary disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant chronic obstructive pulmonary disease",
                    "criterion": "chronic obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study",
                    "criterion": "concurrent disease or comorbid condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}