{
"info": {
"nct_id": "NCT02290366",
"official_title": "Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer",
"inclusion_criteria": "* Histologically confirmed adenocarcinoma of the prostate\n* Clinical stage T1c-T2aN0M0\n* Gleason score <= 3+3=6\n* prostate specific antigen (PSA) <10 ng/ml\n* <= 2 cores positive out of a minimum of 12 cores sampled\nHealthy volunteers allowed\nMust be MALE",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histologically confirmed adenocarcinoma of the prostate",
"criterions": [
{
"exact_snippets": "Histologically confirmed adenocarcinoma of the prostate",
"criterion": "adenocarcinoma of the prostate",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
]
}
]
},
{
"line": "* Clinical stage T1c-T2aN0M0",
"criterions": [
{
"exact_snippets": "Clinical stage T1c-T2aN0M0",
"criterion": "clinical stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "T"
},
{
"operator": "<=",
"value": 2,
"unit": "T"
}
]
}
},
{
"requirement_type": "N stage",
"expected_value": "0"
},
{
"requirement_type": "M stage",
"expected_value": "0"
}
]
}
]
},
{
"line": "* Gleason score <= 3+3=6",
"criterions": [
{
"exact_snippets": "Gleason score <= 3+3=6",
"criterion": "Gleason score",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* prostate specific antigen (PSA) <10 ng/ml",
"criterions": [
{
"exact_snippets": "prostate specific antigen (PSA) <10 ng/ml",
"criterion": "prostate specific antigen (PSA)",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "ng/ml"
}
}
]
}
]
},
{
"line": "* <= 2 cores positive out of a minimum of 12 cores sampled",
"criterions": [
{
"exact_snippets": "<= 2 cores positive ... out of a minimum of 12 cores sampled",
"criterion": "positive cores",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "cores"
}
},
{
"requirement_type": "sample size",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "cores"
}
}
]
}
]
},
{
"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"
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}