{
"info": {
"nct_id": "NCT03159676",
"official_title": "Proton-Based Stereotactic Ablative Body Radiotherapy (SABR) for Select Patients With Clinically Localized Prostate Cancer.",
"inclusion_criteria": "* Male, age ≥ 18 years.\n* Histological confirmation of adenocarcinoma of prostatic origin.\n* AJCC 7th edition clinical T1b-fdiabetes mellitus T2b.\n* AJCC clinical staging rules do not include findings from biopsy or imaging.\n* Gleason score ≤7 (International Society of Urological Pathologists grades 1-3).\n* Serum prostate-specific antigen ≤20 ng/mL.\n* Prostate-specific antigen <10 ng/mL, if dutasteride within last 90 days or finasteride within last 30 days.\n* Zubrod performance score 0-1.\n* Prostate volume <75-cc, determined by ultrasound, computed tomography or magnetic resonance imaging (modality with lesser volume is acceptable).\n* If neoadjuvant-concurrent androgen suppression is used, the prostate volume after the start of androgen suppression may be used.\n* American Urological Association voiding symptom index ≤15.\n* Ability to complete questionnaire(s) by themselves or with assistance.\n* Participation in a patient-reported outcomes survey program, inclusive of the Expanded Prostate Index Composite and CTCAE instruments.\n* Ability to provide informed written consent.\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Radiological- or pathologically-confirmed seminal vesicle invasion, lymph node involvement, or distant metastatic disease.\n\n * Radiological- or biopsy-confirmed extraprostatic tumor extension without AJCC 7th edition clinical T3a classification remain eligible.\n* Prior or anticipated external radiotherapy or brachytherapy, transurethral resection of the prostate, prostatic cryoablation/focused ultrasound/laser therapy, prostatectomy, or prostatic enucleation.\n* Prior bilateral orchiectomy, planned long-term (>6 months duration) androgen suppression or peripheral androgen blockade, or chemotherapy or immunotherapy for prostate cancer.\n* Prior hemi- or total hip arthroplasty.\n* Diabetes mellitus associated with vascular ulcers or wound healing problems, ulcerative colitis, connective tissue disorder, or chronic (≥120 days) warfarin or clotting factor inhibitor (e.g., rivaroxaban) use planned.\n* Co-morbid severe concurrent disease which, in the judgment of the investigator, would result in life expectancy <5 years.\n\n * Patients with a left cardiac ventricular assist device are ineligible.\n * Patients with an implanted medical electronic device (e.g., cardiac pacemaker) remain eligible if device monitoring complies with standard of practice (e.g., Cardiology and Medical Physics evaluation, function checks and during-treatment monitoring).\n* Immunocompromised due to HIV positive state.\n* Medical or psychiatric conditions that preclude informed decision-making or adherence.\n* Prior registration to an Institutional Review Board-approved therapeutic research study that includes proton beam therapy or photon-based radiotherapy (e.g., randomization to proton beam therapy vs. photon-based radiotherapy).\n\n * Registration to a non-therapeutic (e.g., biomarker, medical physics) only research study is not an exclusion.\n* Inability to start radiation per protocol.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Male, age ≥ 18 years.",
"criterions": [
{
"exact_snippets": "Male",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"exact_snippets": "age ≥ 18 years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Male",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"exact_snippets": "age ≥ 18 years",
"criterion": "age",
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"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histological confirmation of adenocarcinoma of prostatic origin.",
"criterions": [
{
"exact_snippets": "Histological confirmation of adenocarcinoma of prostatic origin.",
"criterion": "adenocarcinoma of prostatic origin",
"requirement": {
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"expected_value": "histological"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Histological confirmation of adenocarcinoma of prostatic origin.",
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"requirement": {
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"expected_value": "histological"
}
}
]
}
},
{
"identified_line": {
"line": "* AJCC 7th edition clinical T1b-fdiabetes mellitus T2b.",
"criterions": [
{
"exact_snippets": "AJCC 7th edition clinical T1b",
"criterion": "AJCC 7th edition clinical stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "T1b"
}
},
{
"exact_snippets": "diabetes mellitus",
"criterion": "diabetes mellitus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "T2b",
"criterion": "AJCC 7th edition clinical stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "T2b"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "AJCC 7th edition clinical T1b",
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}
},
{
"exact_snippets": "T2b",
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"requirement": {
"requirement_type": "stage",
"expected_value": "T2b"
}
}
]
},
{
"exact_snippets": "diabetes mellitus",
"criterion": "diabetes mellitus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* AJCC clinical staging rules do not include findings from biopsy or imaging.",
"criterions": [
{
"exact_snippets": "AJCC clinical staging rules do not include findings from biopsy",
"criterion": "AJCC clinical staging rules",
"requirement": {
"requirement_type": "inclusion",
"expected_value": false
}
},
{
"exact_snippets": "AJCC clinical staging rules do not include findings from ... imaging",
"criterion": "AJCC clinical staging rules",
"requirement": {
"requirement_type": "inclusion",
"expected_value": false
}
}
]
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"exact_snippets": "AJCC clinical staging rules do not include findings from biopsy",
"criterion": "AJCC clinical staging rules",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "AJCC clinical staging rules do not include findings from ... imaging",
"criterion": "AJCC clinical staging rules",
"requirement": {
"requirement_type": "inclusion",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Gleason score ≤7 (International Society of Urological Pathologists grades 1-3).",
"criterions": [
{
"exact_snippets": "Gleason score ≤7",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "N/A"
}
}
},
{
"exact_snippets": "International Society of Urological Pathologists grades 1-3",
"criterion": "International Society of Urological Pathologists grade",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Gleason score ≤7",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "N/A"
}
}
},
{
"exact_snippets": "International Society of Urological Pathologists grades 1-3",
"criterion": "International Society of Urological Pathologists grade",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum prostate-specific antigen ≤20 ng/mL.",
"criterions": [
{
"exact_snippets": "Serum prostate-specific antigen ≤20 ng/mL",
"criterion": "serum prostate-specific antigen",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 20,
"unit": "ng/mL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Serum prostate-specific antigen ≤20 ng/mL",
"criterion": "serum prostate-specific antigen",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 20,
"unit": "ng/mL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Prostate-specific antigen <10 ng/mL, if dutasteride within last 90 days or finasteride within last 30 days.",
"criterions": [
{
"exact_snippets": "Prostate-specific antigen <10 ng/mL",
"criterion": "prostate-specific antigen",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "ng/mL"
}
}
},
{
"exact_snippets": "if dutasteride within last 90 days",
"criterion": "dutasteride usage",
"requirement": {
"requirement_type": "time since last use",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days"
}
}
},
{
"exact_snippets": "if ... finasteride within last 30 days",
"criterion": "finasteride usage",
"requirement": {
"requirement_type": "time since last use",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"condition": {
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{
"exact_snippets": "if dutasteride within last 90 days",
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"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days"
}
}
},
{
"exact_snippets": "if ... finasteride within last 30 days",
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"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
]
},
"then_criteria": {
"exact_snippets": "Prostate-specific antigen <10 ng/mL",
"criterion": "prostate-specific antigen",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 10,
"unit": "ng/mL"
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Zubrod performance score 0-1.",
"criterions": [
{
"exact_snippets": "Zubrod performance score 0-1",
"criterion": "Zubrod performance score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
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"exact_snippets": "Zubrod performance score 0-1",
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* If neoadjuvant-concurrent androgen suppression is used, the prostate volume after the start of androgen suppression may be used.",
"criterions": [
{
"exact_snippets": "neoadjuvant-concurrent androgen suppression is used",
"criterion": "neoadjuvant-concurrent androgen suppression",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "prostate volume after the start of androgen suppression may be used",
"criterion": "prostate volume",
"requirement": {
"requirement_type": "measurement timing",
"expected_value": "after the start of androgen suppression"
}
}
]
},
"logical_structure": {
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"criterion": "neoadjuvant-concurrent androgen suppression",
"requirement": {
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"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "prostate volume after the start of androgen suppression may be used",
"criterion": "prostate volume",
"requirement": {
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}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* American Urological Association voiding symptom index ≤15.",
"criterions": [
{
"exact_snippets": "American Urological Association voiding symptom index ≤15",
"criterion": "American Urological Association voiding symptom index",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 15,
"unit": "N/A"
}
}
}
]
},
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}
}
}
]
}
},
{
"identified_line": {
"line": "* Ability to complete questionnaire(s) by themselves or with assistance.",
"criterions": [
{
"exact_snippets": "Ability to complete questionnaire(s) by themselves or with assistance.",
"criterion": "ability to complete questionnaire",
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"with assistance"
]
}
}
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"exact_snippets": "Ability to complete questionnaire(s) by themselves or with assistance.",
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]
}
}
]
}
},
{
"identified_line": {
"line": "* Participation in a patient-reported outcomes survey program, inclusive of the Expanded Prostate Index Composite and CTCAE instruments.",
"criterions": [
{
"exact_snippets": "Participation in a patient-reported outcomes survey program",
"criterion": "participation in patient-reported outcomes survey program",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "inclusive of the Expanded Prostate Index Composite",
"criterion": "Expanded Prostate Index Composite",
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"expected_value": true
}
},
{
"exact_snippets": "inclusive of ... CTCAE instruments",
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}
]
},
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"exact_snippets": "Participation in a patient-reported outcomes survey program",
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"expected_value": true
}
},
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"exact_snippets": "inclusive of the Expanded Prostate Index Composite",
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"expected_value": true
}
},
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"exact_snippets": "inclusive of ... CTCAE instruments",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Ability to provide informed written consent.",
"criterions": [
{
"exact_snippets": "Ability to provide informed written consent.",
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"expected_value": true
}
}
]
},
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"exact_snippets": "Ability to provide informed written consent.",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "MALE",
"criterion": "gender",
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"expected_value": "male"
}
}
]
},
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"exact_snippets": "MALE",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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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": "minimum age of 18 Years",
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"operator": ">=",
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"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Radiological- or pathologically-confirmed seminal vesicle invasion, lymph node involvement, or distant metastatic disease.",
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{
"exact_snippets": "Radiological- or pathologically-confirmed seminal vesicle invasion",
"criterion": "seminal vesicle invasion",
"requirement": {
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"pathological"
]
}
},
{
"exact_snippets": "Radiological- or pathologically-confirmed ... lymph node involvement",
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"pathological"
]
}
},
{
"exact_snippets": "Radiological- or pathologically-confirmed ... distant metastatic disease",
"criterion": "distant metastatic disease",
"requirement": {
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"pathological"
]
}
}
]
},
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"and_criteria": [
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"pathological"
]
}
}
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"and_criteria": [
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"exact_snippets": "Radiological- or pathologically-confirmed ... lymph node involvement",
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"pathological"
]
}
}
]
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"and_criteria": [
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]
}
}
]
}
]
}
},
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"identified_line": {
"line": "* Radiological- or biopsy-confirmed extraprostatic tumor extension without AJCC 7th edition clinical T3a classification remain eligible.",
"criterions": [
{
"exact_snippets": "Radiological- or biopsy-confirmed extraprostatic tumor extension",
"criterion": "extraprostatic tumor extension",
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"biopsy"
]
}
},
{
"exact_snippets": "without AJCC 7th edition clinical T3a classification",
"criterion": "AJCC 7th edition clinical T3a classification",
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"expected_value": false
}
}
]
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"and_criteria": [
{
"exact_snippets": "Radiological- or biopsy-confirmed extraprostatic tumor extension",
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]
}
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"not_criteria": {
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"criterion": "AJCC 7th edition clinical T3a classification",
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}
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"line": "* Prior or anticipated external radiotherapy or brachytherapy, transurethral resection of the prostate, prostatic cryoablation/focused ultrasound/laser therapy, prostatectomy, or prostatic enucleation.",
"criterions": [
{
"exact_snippets": "Prior or anticipated external radiotherapy",
"criterion": "external radiotherapy",
"requirement": {
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"expected_value": true
}
},
{
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}
},
{
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"expected_value": true
}
},
{
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"requirement_type": "prior or anticipated",
"expected_value": true
}
},
{
"exact_snippets": "Prior or anticipated ... prostatectomy",
"criterion": "prostatectomy",
"requirement": {
"requirement_type": "prior or anticipated",
"expected_value": true
}
},
{
"exact_snippets": "Prior or anticipated ... prostatic enucleation",
"criterion": "prostatic enucleation",
"requirement": {
"requirement_type": "prior or anticipated",
"expected_value": true
}
}
]
},
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{
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"expected_value": true
}
},
{
"exact_snippets": "Prior or anticipated ... brachytherapy",
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"expected_value": true
}
},
{
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"expected_value": true
}
},
{
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"expected_value": true
}
},
{
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"criterion": "prostatectomy",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Prior or anticipated ... prostatic enucleation",
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}
}
]
}
},
{
"identified_line": {
"line": "* Prior bilateral orchiectomy, planned long-term (>6 months duration) androgen suppression or peripheral androgen blockade, or chemotherapy or immunotherapy for prostate cancer.",
"criterions": [
{
"exact_snippets": "Prior bilateral orchiectomy",
"criterion": "bilateral orchiectomy",
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{
"exact_snippets": "planned long-term (>6 months duration) androgen suppression",
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"operator": ">",
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}
}
},
{
"exact_snippets": "planned long-term (>6 months duration) ... peripheral androgen blockade",
"criterion": "peripheral androgen blockade",
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"requirement_type": "duration",
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"operator": ">",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "chemotherapy ... for prostate cancer",
"criterion": "chemotherapy for prostate cancer",
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"expected_value": true
}
},
{
"exact_snippets": "immunotherapy for prostate cancer",
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},
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{
"and_criteria": [
{
"exact_snippets": "Prior bilateral orchiectomy",
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}
}
]
},
{
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{
"exact_snippets": "planned long-term (>6 months duration) androgen suppression",
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"operator": ">",
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}
}
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},
{
"and_criteria": [
{
"exact_snippets": "planned long-term (>6 months duration) ... peripheral androgen blockade",
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"operator": ">",
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}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "chemotherapy ... for prostate cancer",
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}
}
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},
{
"and_criteria": [
{
"exact_snippets": "immunotherapy for prostate cancer",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Prior hemi- or total hip arthroplasty.",
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{
"exact_snippets": "Prior hemi- or total hip arthroplasty.",
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"requirement_type": "type",
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"hemi",
"total"
]
}
},
{
"exact_snippets": "Prior hemi- or total hip arthroplasty.",
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}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Prior hemi- or total hip arthroplasty.",
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"hemi",
"total"
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}
},
{
"exact_snippets": "Prior hemi- or total hip arthroplasty.",
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}
}
]
}
},
{
"identified_line": {
"line": "* Diabetes mellitus associated with vascular ulcers or wound healing problems, ulcerative colitis, connective tissue disorder, or chronic (≥120 days) warfarin or clotting factor inhibitor (e.g., rivaroxaban) use planned.",
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{
"exact_snippets": "Diabetes mellitus associated with vascular ulcers or wound healing problems",
"criterion": "diabetes mellitus",
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"requirement_type": "association",
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"vascular ulcers",
"wound healing problems"
]
}
},
{
"exact_snippets": "ulcerative colitis",
"criterion": "ulcerative colitis",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "connective tissue disorder",
"criterion": "connective tissue disorder",
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}
},
{
"exact_snippets": "chronic (≥120 days) warfarin or clotting factor inhibitor (e.g., rivaroxaban) use planned",
"criterion": "warfarin or clotting factor inhibitor use",
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"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 120,
"unit": "days"
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}
},
{
"exact_snippets": "chronic (≥120 days) warfarin or clotting factor inhibitor (e.g., rivaroxaban) use planned",
"criterion": "warfarin or clotting factor inhibitor use",
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}
}
]
},
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{
"and_criteria": [
{
"exact_snippets": "Diabetes mellitus associated with vascular ulcers or wound healing problems",
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"vascular ulcers",
"wound healing problems"
]
}
}
]
},
{
"exact_snippets": "ulcerative colitis",
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}
},
{
"exact_snippets": "connective tissue disorder",
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{
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"value": 120,
"unit": "days"
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}
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{
"exact_snippets": "chronic (≥120 days) warfarin or clotting factor inhibitor (e.g., rivaroxaban) use planned",
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},
{
"identified_line": {
"line": "* Co-morbid severe concurrent disease which, in the judgment of the investigator, would result in life expectancy <5 years.",
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"exact_snippets": "Co-morbid severe concurrent disease",
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},
{
"exact_snippets": "life expectancy <5 years",
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"operator": "<",
"value": 5,
"unit": "years"
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}
}
]
},
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{
"exact_snippets": "Co-morbid severe concurrent disease",
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},
{
"exact_snippets": "life expectancy <5 years",
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"operator": "<",
"value": 5,
"unit": "years"
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}
]
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Patients with an implanted medical electronic device (e.g., cardiac pacemaker) remain eligible if device monitoring complies with standard of practice (e.g., Cardiology and Medical Physics evaluation, function checks and during-treatment monitoring).",
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{
"exact_snippets": "implanted medical electronic device (e.g., cardiac pacemaker)",
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"requirement_type": "presence",
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{
"exact_snippets": "device monitoring complies with standard of practice",
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}
]
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}
},
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"exact_snippets": "device monitoring complies with standard of practice",
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}
},
{
"identified_line": {
"line": "* Immunocompromised due to HIV positive state.",
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{
"exact_snippets": "Immunocompromised due to HIV positive state",
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"requirement_type": "presence",
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}
]
},
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"exact_snippets": "Immunocompromised due to HIV positive state",
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}
}
}
},
{
"identified_line": {
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}
},
{
"exact_snippets": "Medical or psychiatric conditions that preclude ... adherence",
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}
}
]
},
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},
{
"exact_snippets": "Medical or psychiatric conditions that preclude ... adherence",
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}
}
]
}
},
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"identified_line": {
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}
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"exact_snippets": "Registration to a non-therapeutic (e.g., biomarker, medical physics) only research study",
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}
]
}
},
{
"identified_line": {
"line": "* Inability to start radiation per protocol.",
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{
"exact_snippets": "Inability to start radiation per protocol.",
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"requirement_type": "ability",
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}
}
]
},
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"exact_snippets": "Inability to start radiation per protocol.",
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"requirement_type": "ability",
"expected_value": true
}
}
}
}
],
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{
"identified_line": {
"line": "* Prostate volume <75-cc, determined by ultrasound, computed tomography or magnetic resonance imaging (modality with lesser volume is acceptable).",
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{
"exact_snippets": "Prostate volume <75-cc",
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"operator": "<",
"value": 75,
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"exact_snippets": "determined by ultrasound, computed tomography or magnetic resonance imaging",
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}
}
]
},
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}
}
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],
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{
"identified_line": {
"line": "* Patients with a left cardiac ventricular assist device are ineligible.",
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{
"exact_snippets": "Patients with a left cardiac ventricular assist device are ineligible.",
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}
}
]
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}
}
}
},
{
"identified_line": {
"line": "* Prior registration to an Institutional Review Board-approved therapeutic research study that includes proton beam therapy or photon-based radiotherapy (e.g., randomization to proton beam therapy vs. photon-based radiotherapy).",
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{
"exact_snippets": "Prior registration to an Institutional Review Board-approved therapeutic research study",
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}
},
{
"exact_snippets": "includes proton beam therapy or photon-based radiotherapy",
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}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Prior registration to an Institutional Review Board-approved therapeutic research study",
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}
},
{
"or_criteria": [
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}
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{
"exact_snippets": "includes proton beam therapy or photon-based radiotherapy",
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}
}
]
}
]
}
]
}
}
],
"failed_miscellaneous": []
}