{
"info": {
"nct_id": "NCT01098331",
"official_title": "Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study",
"inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS\n\nMeeting 1 of the following criteria:\n\n* Prostate cancer or suspected prostate cancer confined to the prostate (Decision-Aid Randomization) Clinical stage T1/T2, Due for prostate biopsy or prostate biopsy performed in the last 6 weeks, PSA < 15 ng/mL\n* Histologically confirmed prostate cancer (Treatment Randomization): Clinical stage T1/T2, Re-biopsy after a period of active surveillance is at the discretion of the treating investigator, Must meet 1 of the following risk criteria (PSA test < 3 months prior to treatment intervention), Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of < 10 ng/mL, intermediate-risk: Gleason score 3 + 4 (no tertiary grade 5) with a PSA > 10 ng/mL but ≤ 15 ng/mL, Transrectal ultrasound prostate volume ≤ 50 cc\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-1\n* Life expectancy > 10 years (Decision-Aid Randomization)\n* Satisfactory results from biochemical and hematological profiles that, in the opinion of the investigator, does not preclude patient from the trial\n* No unacceptable risk for radical prostatectomy or prostate brachytherapy\n* INR < 1.5\n* No severe lower urinary tract symptoms\n* No significant obstructive urinary symptoms (i.e., peak urine flow rate < 10 mL per second, and/or post micturition bladder volume > 100 mL)\n* No other clinical or medical condition that, in the opinion of the investigator, precludes patient from taking part in the trial\n* No other active malignancy likely to interfere with subsequent protocol treatment and follow-up\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior pelvic radiotherapy\n* No prior abdominoperineal (AP) rectal excision\n* No prior standard transurethral resection of prostate\n* No prior or concurrent neoadjuvant or adjuvant hormonal treatment, (e.g., LHRH agonists, or anti-androgens or estrogens)\n* At least 5 days since prior aspirin or clopidogrel\n* No concurrent warfarin"
},
"inclusion_lines": [
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"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
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}
},
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}
]
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}
]
}
},
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"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
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"exact_snippets": "maximum age of 120 Years",
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"unit": "Years"
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"unit": "Years"
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"exclusion_lines": [],
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}
]
}
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{
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"criterion": "prostate cancer",
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"expected_value": true
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{
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"requirement": {
"requirement_type": "location",
"expected_value": "prostate"
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{
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}
},
{
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}
},
{
"exact_snippets": "PSA < 15 ng/mL",
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"operator": "<",
"value": 15,
"unit": "ng/mL"
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"and_criteria": [
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"and_criteria": [
{
"and_criteria": [
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"and_criteria": [
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{
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"unit": "ng/mL"
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{
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"line": "* Histologically confirmed prostate cancer (Treatment Randomization): Clinical stage T1/T2, Re-biopsy after a period of active surveillance is at the discretion of the treating investigator, Must meet 1 of the following risk criteria (PSA test < 3 months prior to treatment intervention), Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of < 10 ng/mL, intermediate-risk: Gleason score 3 + 4 (no tertiary grade 5) with a PSA > 10 ng/mL but ≤ 15 ng/mL, Transrectal ultrasound prostate volume ≤ 50 cc",
"criterions": [
{
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"expected_value": "histologically confirmed"
}
},
{
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"requirement_type": "stage",
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"T1",
"T2"
]
}
},
{
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"criterion": "re-biopsy",
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"expected_value": "treating investigator"
}
},
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"operator": "<",
"value": 3,
"unit": "months"
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}
},
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"operator": "<=",
"value": 6,
"unit": "N/A"
}
}
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"unit": "ng/mL"
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"expected_value": "3 + 4"
}
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"expected_value": "not 5"
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"unit": "ng/mL"
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"exact_snippets": "Life expectancy > 10 years",
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"exact_snippets": "Satisfactory results from biochemical ... profiles",
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}
},
{
"exact_snippets": "Satisfactory results from ... hematological profiles",
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{
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}
}
]
}
},
{
"identified_line": {
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"exact_snippets": "PRIOR CONCURRENT THERAPY",
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}
]
},
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"exact_snippets": "PRIOR CONCURRENT THERAPY",
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}
}
]
}
},
{
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}
]
},
"logical_structure": {
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"exact_snippets": "No prior standard transurethral resection of prostate",
"criterion": "prior standard transurethral resection of prostate",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* No prior or concurrent neoadjuvant or adjuvant hormonal treatment, (e.g., LHRH agonists, or anti-androgens or estrogens)",
"criterions": [
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"exact_snippets": "No prior or concurrent neoadjuvant or adjuvant hormonal treatment",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "LHRH agonists",
"criterion": "LHRH agonists",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "anti-androgens",
"criterion": "anti-androgens",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "estrogens",
"criterion": "estrogens",
"requirement": {
"requirement_type": "presence",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No prior or concurrent neoadjuvant or adjuvant hormonal treatment",
"criterion": "hormonal treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "LHRH agonists",
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"requirement_type": "presence",
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}
}
]
},
{
"exact_snippets": "anti-androgens",
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},
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"requirement_type": "presence",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* At least 5 days since prior aspirin or clopidogrel",
"criterions": [
{
"exact_snippets": "At least 5 days since prior aspirin",
"criterion": "aspirin usage",
"requirement": {
"requirement_type": "time since last use",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "days"
}
}
},
{
"exact_snippets": "At least 5 days since prior ... clopidogrel",
"criterion": "clopidogrel usage",
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"requirement_type": "time since last use",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "At least 5 days since prior aspirin",
"criterion": "aspirin usage",
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"requirement_type": "time since last use",
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"operator": ">=",
"value": 5,
"unit": "days"
}
}
},
{
"exact_snippets": "At least 5 days since prior ... clopidogrel",
"criterion": "clopidogrel usage",
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"requirement_type": "time since last use",
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"operator": ">=",
"value": 5,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No concurrent warfarin",
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{
"exact_snippets": "No concurrent warfarin",
"criterion": "warfarin use",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No concurrent warfarin",
"criterion": "warfarin use",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* No prior pelvic radiotherapy",
"criterions": [
{
"exact_snippets": "No prior pelvic radiotherapy",
"criterion": "pelvic radiotherapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No prior pelvic radiotherapy",
"criterion": "pelvic radiotherapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No prior abdominoperineal (AP) rectal excision",
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{
"exact_snippets": "No prior abdominoperineal (AP) rectal excision",
"criterion": "abdominoperineal (AP) rectal excision",
"requirement": {
"requirement_type": "prior occurrence",
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}
}
]
},
"logical_structure": {
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"exact_snippets": "No prior abdominoperineal (AP) rectal excision",
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"requirement_type": "prior occurrence",
"expected_value": true
}
}
}
}
]
}