{
"info": {
"nct_id": "NCT03322020",
"official_title": "Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer",
"inclusion_criteria": "* Pathologically confirmed intermediate- or high-risk prostate cancer within 6 months after enrollment\n* ECOG performance status 0-1\n* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl\n* Appropriate values of kidney function within 6 months after enrollment Creatinine < 2.0 ng/dL\n* Appropriate values of liver function within 6 months after enrollment total bilirubin < 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase < 2.5 X maximum normal value\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 20 Years",
"exclusion_criteria": "* Presence of distant metastasis\n* Presence of pelvic LN metastasis\n* History of androgen deprivation therapy within 6 months after enrollment\n* History of definitive treatment for prostate cancer (e.g., radical prostatectomy)\n* History of pelvic irradiation\n* Double primary cancer other than skin/thyroid cancer",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Pathologically confirmed intermediate- or high-risk prostate cancer within 6 months after enrollment",
"criterions": [
{
"exact_snippets": "Pathologically confirmed intermediate- or high-risk prostate cancer",
"criterion": "prostate cancer risk level",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
},
{
"requirement_type": "risk level",
"expected_value": [
"intermediate",
"high"
]
}
]
},
{
"exact_snippets": "within 6 months after enrollment",
"criterion": "time since enrollment",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
}
]
},
{
"line": "* ECOG performance status 0-1",
"criterions": [
{
"exact_snippets": "ECOG performance status 0-1",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count (ANC) ≥ 1500 cells/mm3",
"criterion": "absolute neutrophil count (ANC)",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "cells/mm3"
}
}
]
},
{
"exact_snippets": "Platelets ≥ 50,000 cells/mm3",
"criterion": "platelets",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 50000,
"unit": "cells/mm3"
}
}
]
},
{
"exact_snippets": "Hemoglobin ≥ 8.0 g/dl",
"criterion": "hemoglobin",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 8.0,
"unit": "g/dl"
}
}
]
}
]
},
{
"line": "* Appropriate values of kidney function within 6 months after enrollment Creatinine < 2.0 ng/dL",
"criterions": [
{
"exact_snippets": "Appropriate values of kidney function",
"criterion": "kidney function",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "within 6 months after enrollment"
}
]
},
{
"exact_snippets": "Creatinine < 2.0 ng/dL",
"criterion": "creatinine level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "ng/dL"
}
}
]
}
]
},
{
"line": "* Appropriate values of liver function within 6 months after enrollment total bilirubin < 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase < 2.5 X maximum normal value",
"criterions": [
{
"exact_snippets": "liver function within 6 months after enrollment",
"criterion": "liver function",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within 6 months after enrollment"
}
]
},
{
"exact_snippets": "total bilirubin < 1.5 X maximum normal value",
"criterion": "total bilirubin",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 1.5,
"unit": "X maximum normal value"
}
}
]
},
{
"exact_snippets": "alanine aminotransferase or aspartate aminotransferase < 2.5 X maximum normal value",
"criterion": "alanine aminotransferase or aspartate aminotransferase",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "X maximum normal value"
}
}
]
}
]
},
{
"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"
}
]
}
]
},
{
"line": "Must have minimum age of 20 Years",
"criterions": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Presence of distant metastasis",
"criterions": [
{
"exact_snippets": "Presence of distant metastasis",
"criterion": "distant metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Presence of pelvic LN metastasis",
"criterions": [
{
"exact_snippets": "Presence of pelvic LN metastasis",
"criterion": "pelvic LN metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of androgen deprivation therapy within 6 months after enrollment",
"criterions": [
{
"exact_snippets": "History of androgen deprivation therapy within 6 months after enrollment",
"criterion": "androgen deprivation therapy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* History of definitive treatment for prostate cancer (e.g., radical prostatectomy)",
"criterions": [
{
"exact_snippets": "History of definitive treatment for prostate cancer",
"criterion": "definitive treatment for prostate cancer",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "radical prostatectomy",
"criterion": "radical prostatectomy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* History of pelvic irradiation",
"criterions": [
{
"exact_snippets": "History of pelvic irradiation",
"criterion": "pelvic irradiation",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Double primary cancer other than skin/thyroid cancer",
"criterions": [
{
"exact_snippets": "Double primary cancer",
"criterion": "double primary cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "other than skin/thyroid cancer",
"criterion": "skin/thyroid cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}