{
"info": {
"nct_id": "NCT05123391",
"official_title": "Technical Feasibility of a Randomized Pilot Study of Radiosurgery for the Treatment of Non-metastatic Prostate Cancer",
"inclusion_criteria": "* Histology confirmed prostate cancer\n* Disease confined to the pelvis by imaging CT (CT scan of chest, abdomen and pelvis and bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines)\n* Eastern Cooperative Oncology Group (ECOG) performance 0-1\n* Eligible for curative radiotherapy\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Metastasis beyond the pelvis\n* Poor performance ECOG 2-4\n* Cannot follow directions to prepare for simulation (bladder filling and rectal emptying)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histology confirmed prostate cancer",
"criterions": [
{
"exact_snippets": "Histology confirmed prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histology"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histology confirmed prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histology"
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance 0-1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance 0-1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance 0-1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eligible for curative radiotherapy",
"criterions": [
{
"exact_snippets": "Eligible for curative radiotherapy",
"criterion": "curative radiotherapy eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eligible for curative radiotherapy",
"criterion": "curative radiotherapy eligibility",
"requirement": {
"requirement_type": "eligibility",
"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": "MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "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": "* Metastasis beyond the pelvis",
"criterions": [
{
"exact_snippets": "Metastasis beyond the pelvis",
"criterion": "metastasis",
"requirement": {
"requirement_type": "location",
"expected_value": "beyond the pelvis"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Metastasis beyond the pelvis",
"criterion": "metastasis",
"requirement": {
"requirement_type": "location",
"expected_value": "beyond the pelvis"
}
}
]
}
},
{
"identified_line": {
"line": "* Poor performance ECOG 2-4",
"criterions": [
{
"exact_snippets": "Poor performance ECOG 2-4",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 4,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Poor performance ECOG 2-4",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 4,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Cannot follow directions to prepare for simulation (bladder filling and rectal emptying)",
"criterions": [
{
"exact_snippets": "Cannot follow directions to prepare for simulation (bladder filling and rectal emptying)",
"criterion": "ability to follow directions for simulation preparation",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cannot follow directions to prepare for simulation (bladder filling and rectal emptying)",
"criterion": "ability to follow directions for simulation preparation",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Disease confined to the pelvis by imaging CT (CT scan of chest, abdomen and pelvis and bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines)",
"criterions": [
{
"exact_snippets": "Disease confined to the pelvis by imaging CT",
"criterion": "disease location",
"requirement": {
"requirement_type": "location",
"expected_value": "pelvis"
}
},
{
"exact_snippets": "CT scan of chest, abdomen and pelvis",
"criterion": "imaging requirement",
"requirement": {
"requirement_type": "imaging type",
"expected_value": "CT scan"
}
},
{
"exact_snippets": "CT scan of chest, abdomen and pelvis",
"criterion": "imaging requirement",
"requirement": {
"requirement_type": "imaging areas",
"expected_value": [
"chest",
"abdomen",
"pelvis"
]
}
},
{
"exact_snippets": "bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines",
"criterion": "additional imaging",
"requirement": {
"requirement_type": "imaging type",
"expected_value": [
"bone scan",
"PET-PSMA"
]
}
},
{
"exact_snippets": "bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines",
"criterion": "additional imaging",
"requirement": {
"requirement_type": "condition",
"expected_value": "if required according to local guidelines"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Disease confined to the pelvis by imaging CT",
"criterion": "disease location",
"requirement": {
"requirement_type": "location",
"expected_value": "pelvis"
}
},
{
"and_criteria": [
{
"exact_snippets": "CT scan of chest, abdomen and pelvis",
"criterion": "imaging requirement",
"requirement": {
"requirement_type": "imaging type",
"expected_value": "CT scan"
}
},
{
"exact_snippets": "CT scan of chest, abdomen and pelvis",
"criterion": "imaging requirement",
"requirement": {
"requirement_type": "imaging areas",
"expected_value": [
"chest",
"abdomen",
"pelvis"
]
}
}
]
}
]
},
{
"or_criteria": [
{
"exact_snippets": "bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines",
"criterion": "additional imaging",
"requirement": {
"requirement_type": "imaging type",
"expected_value": "bone scan"
}
},
{
"exact_snippets": "bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines",
"criterion": "additional imaging",
"requirement": {
"requirement_type": "imaging type",
"expected_value": "PET-PSMA"
}
}
]
},
{
"exact_snippets": "bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines",
"criterion": "additional imaging",
"requirement": {
"requirement_type": "condition",
"expected_value": "if required according to local guidelines"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}