{
"info": {
"nct_id": "NCT01540994",
"official_title": "Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate",
"inclusion_criteria": "* Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 50 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "* Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.",
"criterions": [
{
"exact_snippets": "Male",
"criterion": "gender",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "male"
}
]
},
{
"exact_snippets": "any age",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "any"
}
]
},
{
"exact_snippets": "low risk disease",
"criterion": "disease risk",
"requirements": [
{
"requirement_type": "risk level",
"expected_value": "low"
}
]
},
{
"exact_snippets": "Gleason's score of 6 or less",
"criterion": "Gleason's score",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "clinical stage of T2a or less",
"criterion": "clinical stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "T"
}
}
]
},
{
"exact_snippets": "PSA of less than 15",
"criterion": "PSA level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 15,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "Gleason's score of 3+4=7",
"criterion": "Gleason's score",
"requirements": [
{
"requirement_type": "score",
"expected_value": "3+4=7"
}
]
},
{
"exact_snippets": "fewer than 2 cores positive",
"criterion": "positive cores",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "cores"
}
}
]
},
{
"exact_snippets": "no more than 5mm of tumor in aggregate dimension",
"criterion": "tumor size in aggregate dimension",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "mm"
}
}
]
}
]
},
{
"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 50 Years",
"criterions": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 90 Years",
"criterions": [
{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.",
"criterions": [
{
"exact_snippets": "Prior surgery or radiotherapy for prostate cancer",
"criterion": "prior treatment for prostate cancer",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"surgery",
"radiotherapy"
]
}
]
},
{
"exact_snippets": "PSA over 10",
"criterion": "PSA level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "Gleason scores 7, 8, 9, or 10",
"criterion": "Gleason score",
"requirements": [
{
"requirement_type": "score",
"expected_value": [
"7",
"8",
"9",
"10"
]
}
]
},
{
"exact_snippets": "clinical stage T2b, T2c, T3, or T4",
"criterion": "clinical stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"T2b",
"T2c",
"T3",
"T4"
]
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}