{
"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": [
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "compliance",
"expected_value": "ICH/GCP regulations"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Written informed consent according to ICH/GCP regulations",
"criterion": "informed consent",
"requirement": {
"requirement_type": "compliance",
"expected_value": "ICH/GCP regulations"
}
}
]
}
},
{
"identified_line": {
"line": "* Age ≥ 18 years",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histology of adenocarcinoma of the prostate",
"criterions": [
{
"exact_snippets": "Histology of adenocarcinoma of the prostate",
"criterion": "adenocarcinoma of the prostate",
"requirement": {
"requirement_type": "histology",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histology of adenocarcinoma of the prostate",
"criterion": "adenocarcinoma of the prostate",
"requirement": {
"requirement_type": "histology",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"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)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)",
"criterion": "androgen deprivation therapy (ADT)",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"ADT alone",
"ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients with PCa",
"criterion": "prostate cancer (PCa)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)",
"criterion": "androgen deprivation therapy (ADT)",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"ADT alone",
"ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)"
]
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "trend",
"expected_value": "rising"
}
},
{
"exact_snippets": "Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart)",
"criterion": "PSA levels",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "% above nadir"
}
}
},
{
"exact_snippets": "Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart)",
"criterion": "PSA levels",
"requirement": {
"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",
"requirement": {
"requirement_type": "evidence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart)",
"criterion": "PSA levels",
"requirement": {
"requirement_type": "trend",
"expected_value": "rising"
}
},
{
"exact_snippets": "Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart)",
"criterion": "PSA levels",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "% above nadir"
}
}
}
]
},
{
"exact_snippets": "Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart)",
"criterion": "PSA levels",
"requirement": {
"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",
"requirement": {
"requirement_type": "evidence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* PSA doubling time > 8 weeks",
"criterions": [
{
"exact_snippets": "PSA doubling time > 8 weeks",
"criterion": "PSA doubling time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 8,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PSA doubling time > 8 weeks",
"criterion": "PSA doubling time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 8,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "feasibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Continuation of ongoing systemic treatment is deemed feasible by treating physician",
"criterion": "systemic treatment",
"requirement": {
"requirement_type": "feasibility",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments",
"criterions": [
{
"exact_snippets": "Ongoing treatment with docetaxel",
"criterion": "ongoing treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "docetaxel"
}
},
{
"exact_snippets": "Ongoing treatment with ... cabazitaxel",
"criterion": "ongoing treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "cabazitaxel"
}
},
{
"exact_snippets": "Ongoing treatment with ... radionuclides",
"criterion": "ongoing treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "radionuclides"
}
},
{
"exact_snippets": "Ongoing treatment with ... investigational treatments",
"criterion": "ongoing treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "investigational treatments"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Ongoing treatment with docetaxel",
"criterion": "ongoing treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "docetaxel"
}
},
{
"exact_snippets": "Ongoing treatment with ... cabazitaxel",
"criterion": "ongoing treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "cabazitaxel"
}
},
{
"exact_snippets": "Ongoing treatment with ... radionuclides",
"criterion": "ongoing treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "radionuclides"
}
},
{
"exact_snippets": "Ongoing treatment with ... investigational treatments",
"criterion": "ongoing treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "investigational treatments"
}
}
]
}
},
{
"identified_line": {
"line": "* Evidence of clinical progression or progression of disease on imaging",
"criterions": [
{
"exact_snippets": "Evidence of clinical progression",
"criterion": "clinical progression",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "progression of disease on imaging",
"criterion": "disease progression on imaging",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Evidence of clinical progression",
"criterion": "clinical progression",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "progression of disease on imaging",
"criterion": "disease progression on imaging",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Bone metastases excluding the safety of physical exercise",
"criterions": [
{
"exact_snippets": "Bone metastases",
"criterion": "bone metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "excluding the safety of physical exercise",
"criterion": "safety of physical exercise",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Bone metastases",
"criterion": "bone metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
},
{
"not_criteria": {
"exact_snippets": "excluding the safety of physical exercise",
"criterion": "safety of physical exercise",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures",
"criterions": [
{
"exact_snippets": "Prior confirmed severe osteoporosis",
"criterion": "osteoporosis",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Prior confirmed severe osteoporosis",
"criterion": "osteoporosis",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "other diseases affecting the bone",
"criterion": "diseases affecting the bone",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of fractures",
"criterion": "fractures",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior confirmed severe osteoporosis",
"criterion": "osteoporosis",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Prior confirmed severe osteoporosis",
"criterion": "osteoporosis",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
}
]
},
{
"exact_snippets": "history of fractures",
"criterion": "fractures",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "other diseases affecting the bone",
"criterion": "diseases affecting the bone",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of fractures",
"criterion": "fractures",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 105,
"unit": "mm Hg"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Clinically significant cardiovascular disease ... uncontrolled angina within 3 months before screening",
"criterion": "uncontrolled angina",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Clinically significant cardiovascular disease ... congestive heart failure New York Heart Association class 3 or 4",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"New York Heart Association class 3",
"New York Heart Association class 4"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Clinically significant cardiovascular disease ... history of clinically significant arrhythmias",
"criterion": "clinically significant arrhythmias",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Clinically significant cardiovascular disease ... uncontrolled hypertension indicated by systolic blood pressure > 170 mm Hg",
"criterion": "systolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 170,
"unit": "mm Hg"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Clinically significant cardiovascular disease ... uncontrolled hypertension indicated by ... diastolic blood pressure > 105 mm Hg at screening",
"criterion": "diastolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 105,
"unit": "mm Hg"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Clinically significant chronic obstructive pulmonary disease",
"criterions": [
{
"exact_snippets": "Clinically significant chronic obstructive pulmonary disease",
"criterion": "chronic obstructive pulmonary disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Clinically significant chronic obstructive pulmonary disease",
"criterion": "chronic obstructive pulmonary disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "interference with study participation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"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",
"requirement": {
"requirement_type": "interference with study participation",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}