{
"info": {
"nct_id": "NCT00608920",
"official_title": "SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer",
"inclusion_criteria": "* Patients with biopsy proven adenocarcinoma of the prostate\n* Patients with at least one of the following high risk clinical features at the time of presentation:\n* Extra-prostatic extension (on palpation or radiographic imaging)\n* PSA ≥ 20\n* Gleason Score ≥ 8\n* Patients scheduled to receive prostatic and pelvic IMRT with ACCULOC® target localization\n* Age > 18 years\n* ECOG Performance Status ≤ 2\n* Willing and able to sign informed consent document.-\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* History of radical prostatectomy\n* History of prior pelvic radiation-",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients with biopsy proven adenocarcinoma of the prostate",
"criterions": [
{
"exact_snippets": "biopsy proven adenocarcinoma of the prostate",
"criterion": "adenocarcinoma of the prostate",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "biopsy proven"
}
]
}
]
},
{
"line": "* Patients with at least one of the following high risk clinical features at the time of presentation:",
"criterions": [
{
"exact_snippets": "at least one of the following high risk clinical features",
"criterion": "high risk clinical features",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Extra-prostatic extension (on palpation or radiographic imaging)",
"criterions": [
{
"exact_snippets": "Extra-prostatic extension (on palpation or radiographic imaging)",
"criterion": "extra-prostatic extension",
"requirements": [
{
"requirement_type": "detection method",
"expected_value": [
"palpation",
"radiographic imaging"
]
}
]
}
]
},
{
"line": "* PSA ≥ 20",
"criterions": [
{
"exact_snippets": "PSA ≥ 20",
"criterion": "PSA",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Gleason Score ≥ 8",
"criterions": [
{
"exact_snippets": "Gleason Score ≥ 8",
"criterion": "Gleason Score",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Patients scheduled to receive prostatic and pelvic IMRT with ACCULOC® target localization",
"criterions": [
{
"exact_snippets": "scheduled to receive prostatic and pelvic IMRT",
"criterion": "IMRT treatment",
"requirements": [
{
"requirement_type": "target areas",
"expected_value": [
"prostatic",
"pelvic"
]
}
]
},
{
"exact_snippets": "ACCULOC® target localization",
"criterion": "target localization system",
"requirements": [
{
"requirement_type": "system",
"expected_value": "ACCULOC®"
}
]
}
]
},
{
"line": "* Age > 18 years",
"criterions": [
{
"exact_snippets": "Age > 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* ECOG Performance Status ≤ 2",
"criterions": [
{
"exact_snippets": "ECOG Performance Status ≤ 2",
"criterion": "ECOG Performance Status",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Willing and able to sign informed consent document.-",
"criterions": [
{
"exact_snippets": "Willing and able to sign informed consent document.",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"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": "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": "* History of radical prostatectomy",
"criterions": [
{
"exact_snippets": "History of radical prostatectomy",
"criterion": "radical prostatectomy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* History of prior pelvic radiation-",
"criterions": [
{
"exact_snippets": "History of prior pelvic radiation",
"criterion": "pelvic radiation",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}