{
"info": {
"nct_id": "NCT01834001",
"official_title": "Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies",
"inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "* INCLUSION CRITERIA: men with untreated prostate cancer.\n\n 1. Patients must have histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI.\n 2. Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion).\n 3. No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer.\n 4. Age greater than or equal to18 years.\n 5. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).\n 6. Radiotherapy is planned as definitive therapy for prostate cancer. For patients not treated at NCI ROB patients must have a radiation oncologist who is willing to collaborate with the ROB and provide documentation of treatment.\n 7. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nINCLUSION CRITERIA: for men with presumed prostate cancer relapse\n\n1. Patients must have a history of histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI\n2. Age greater than or equal to 18 years.\n3. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).\n4. Radiotherapy (external beam irradiation alone or in combination with hormonal therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer and documentation is available.\n5. Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive of local failure)\n6. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).\n2. Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria). For patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion.\n3. Patients with coagulopathies who are at increased risk for bleeding or on active anticoagulation therapy (platelets less than 100,000 per mm^3 or PT/PTT greater than 1.5 times the upper normal limit (UNL). Patients are eligible if the underlying cause is correctable.\n4. Subject s weight exceeding MRI or radiation treatment table tolerance.\n5. Patients with active urinary tract infections.\n6. Patients with renal insufficiency with a GFR less than 30, due to the fact that they will not be able to undergo gadolinium enhanced MRI.\n7. Uncontrolled illness or comorbidity that in the judgment of the PI would preclude participation in the study.\n8. Hepatitis B or Hepatitis C active infection.\n9. HIV-positive patients are ineligible because HIV is known to increase radiation toxicity and may result in under-dosing or alterations in the treatment plan that would alter the likelihood of local recurrence. Appropriate studies will be undertaken in HIV positive patients when indicated."
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
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{
"exact_snippets": "MALE",
"criterion": "gender",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"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",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
}
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}
]
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}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* INCLUSION CRITERIA: men with untreated prostate cancer.",
"criterions": [
{
"exact_snippets": "men",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"exact_snippets": "untreated prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
}
]
},
"logical_structure": {
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"exact_snippets": "men",
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{
"exact_snippets": "untreated prostate cancer",
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"expected_value": "untreated"
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}
]
}
},
{
"identified_line": {
"line": "1. Patients must have histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI.",
"criterions": [
{
"exact_snippets": "histologically or cytologically confirmed prostate cancer",
"criterion": "prostate cancer",
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"histologically",
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]
}
}
]
},
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"histologically",
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]
}
},
{
"exact_snippets": "The outside pathology report is acceptable for study entry",
"criterion": "outside pathology report",
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"requirement_type": "acceptability",
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}
}
]
}
},
{
"identified_line": {
"line": "3. No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer.",
"criterions": [
{
"exact_snippets": "No prior local therapy (prostatectomy, radiation, cryotherapy)",
"criterion": "prior local therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior ... hormonal therapy for prostate cancer",
"criterion": "prior hormonal therapy for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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}
},
{
"exact_snippets": "No prior ... hormonal therapy for prostate cancer",
"criterion": "prior hormonal therapy for prostate cancer",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "4. Age greater than or equal to18 years.",
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{
"exact_snippets": "Age greater than or equal to18 years.",
"criterion": "age",
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"requirement_type": "N/A",
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"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
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},
"logical_structure": {
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"exact_snippets": "Age greater than or equal to18 years.",
"criterion": "age",
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"operator": ">=",
"value": 18,
"unit": "years"
}
}
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"identified_line": {
"line": "5. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).",
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{
"exact_snippets": "ECOG performance status less than or equal to 2",
"criterion": "ECOG performance status",
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"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Karnofsky greater than or equal to 60%",
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"operator": ">=",
"value": 60,
"unit": "%"
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}
}
]
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"logical_structure": {
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"value": 2,
"unit": "N/A"
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"exact_snippets": "Karnofsky greater than or equal to 60%",
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"operator": ">=",
"value": 60,
"unit": "%"
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}
}
]
}
},
{
"identified_line": {
"line": "6. Radiotherapy is planned as definitive therapy for prostate cancer. For patients not treated at NCI ROB patients must have a radiation oncologist who is willing to collaborate with the ROB and provide documentation of treatment.",
"criterions": [
{
"exact_snippets": "Radiotherapy is planned as definitive therapy for prostate cancer.",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
},
{
"exact_snippets": "prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patients not treated at NCI ROB ... must have a radiation oncologist who is willing to collaborate with the ROB",
"criterion": "radiation oncologist collaboration",
"requirement": {
"requirement_type": "willingness to collaborate",
"expected_value": true
}
},
{
"exact_snippets": "patients not treated at NCI ROB ... provide documentation of treatment",
"criterion": "treatment documentation",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Radiotherapy is planned as definitive therapy for prostate cancer.",
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{
"condition": {
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"expected_value": true
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"exact_snippets": "patients not treated at NCI ROB ... must have a radiation oncologist who is willing to collaborate with the ROB",
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"expected_value": true
}
},
{
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"else_criteria": null
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},
{
"identified_line": {
"line": "7. Ability of subject to understand and the willingness to sign a written informed consent document.",
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{
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"criterion": "cognitive ability",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
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}
}
]
},
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}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
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}
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}
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{
"identified_line": {
"line": "INCLUSION CRITERIA: for men with presumed prostate cancer relapse",
"criterions": [
{
"exact_snippets": "men",
"criterion": "gender",
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}
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}
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{
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{
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]
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{
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{
"exact_snippets": "Age greater than or equal to 18 years.",
"criterion": "age",
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"value": 18,
"unit": "years"
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"value": 18,
"unit": "years"
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}
}
]
}
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"identified_line": {
"line": "3. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).",
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{
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"value": 2,
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}
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"value": 60,
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"value": 2,
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{
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}
},
{
"identified_line": {
"line": "4. Radiotherapy (external beam irradiation alone or in combination with hormonal therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer and documentation is available.",
"criterions": [
{
"exact_snippets": "Radiotherapy (external beam irradiation alone or in combination with hormonal therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer",
"criterion": "radiotherapy for prostate cancer",
"requirement": {
"requirement_type": "delivery",
"expected_value": true
}
},
{
"exact_snippets": "documentation is available",
"criterion": "documentation",
"requirement": {
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"expected_value": true
}
}
]
},
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"requirement": {
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}
},
{
"exact_snippets": "documentation is available",
"criterion": "documentation",
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"expected_value": true
}
}
]
}
},
{
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"line": "5. Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive of local failure)",
"criterions": [
{
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"criterion": "prostate cancer recurrence",
"requirement": {
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"expected_value": "biochemical relapse by the Phoenix definition"
}
},
{
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"criterion": "prostate cancer recurrence",
"requirement": {
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"expected_value": "enlarging palpable prostatic abnormality"
}
},
{
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"criterion": "prostate cancer recurrence",
"requirement": {
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}
}
]
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}
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}
}
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}
},
{
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{
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}
},
{
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}
]
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},
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}
}
]
}
},
{
"identified_line": {
"line": "8. Hepatitis B or Hepatitis C active infection.",
"criterions": [
{
"exact_snippets": "Hepatitis B ... active infection",
"criterion": "Hepatitis B infection",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "Hepatitis C active infection",
"criterion": "Hepatitis C infection",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
},
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}
},
{
"exact_snippets": "Hepatitis C active infection",
"criterion": "Hepatitis C infection",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
}
},
{
"identified_line": {
"line": "EXCLUSION CRITERIA:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "2. Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion).",
"criterions": [
{
"exact_snippets": "Intermediate or high risk prostate cancer",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "severity",
"expected_value": [
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"high"
]
}
},
{
"exact_snippets": "clinical tumor stage T2b or higher",
"criterion": "clinical tumor stage",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 2.2,
"unit": "T"
}
}
},
{
"exact_snippets": "Gleason 7 or higher",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "N/A"
}
}
},
{
"exact_snippets": "PSA greater than 10",
"criterion": "PSA level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "N/A"
}
}
},
{
"exact_snippets": "MR imaging may be used for clinical T staging",
"criterion": "MR imaging for clinical T staging",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "extracapsular extension",
"criterion": "extracapsular extension",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "seminal vesicle invasion",
"criterion": "seminal vesicle invasion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "clinical tumor stage T2b or higher",
"criterion": "clinical tumor stage",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 2.2,
"unit": "T"
}
}
},
{
"exact_snippets": "MR imaging may be used for clinical T staging",
"criterion": "MR imaging for clinical T staging",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Gleason 7 or higher",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "N/A"
}
}
},
{
"exact_snippets": "PSA greater than 10",
"criterion": "PSA level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "1. Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).",
"criterions": [
{
"exact_snippets": "unable to tolerate MRI",
"criterion": "MRI tolerance",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
},
{
"exact_snippets": "pacemakers",
"criterion": "pacemaker presence",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "cerebral aneurysm clips",
"criterion": "cerebral aneurysm clips presence",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "shrapnel injuries",
"criterion": "shrapnel injuries presence",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "other implantable electronic devices",
"criterion": "implantable electronic devices presence",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "metal not compatible with MRI",
"criterion": "metal compatibility with MRI",
"requirement": {
"requirement_type": "compatibility",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
"exact_snippets": "pacemakers",
"criterion": "pacemaker presence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to tolerate MRI",
"criterion": "MRI tolerance",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "cerebral aneurysm clips",
"criterion": "cerebral aneurysm clips presence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to tolerate MRI",
"criterion": "MRI tolerance",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "shrapnel injuries",
"criterion": "shrapnel injuries presence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to tolerate MRI",
"criterion": "MRI tolerance",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "other implantable electronic devices",
"criterion": "implantable electronic devices presence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to tolerate MRI",
"criterion": "MRI tolerance",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "metal not compatible with MRI",
"criterion": "metal compatibility with MRI",
"requirement": {
"requirement_type": "compatibility",
"expected_value": false
}
},
{
"exact_snippets": "unable to tolerate MRI",
"criterion": "MRI tolerance",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria). For patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion.",
"criterions": [
{
"exact_snippets": "Evidence of metastases",
"criterion": "metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pelvic lymph node involvement is not an exclusion criteria",
"criterion": "pelvic lymph node involvement",
"requirement": {
"requirement_type": "exclusion",
"expected_value": false
}
},
{
"exact_snippets": "recurrent prostate cancer",
"criterion": "recurrent prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion",
"criterion": "oligometastatic disease",
"requirement": {
"requirement_type": "exclusion",
"expected_value": false
}
},
{
"exact_snippets": "oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion",
"criterion": "oligometastatic disease",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "visible metastases"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "3. Patients with coagulopathies who are at increased risk for bleeding or on active anticoagulation therapy (platelets less than 100,000 per mm^3 or PT/PTT greater than 1.5 times the upper normal limit (UNL). Patients are eligible if the underlying cause is correctable.",
"criterions": [
{
"exact_snippets": "Patients with coagulopathies",
"criterion": "coagulopathies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "increased risk for bleeding",
"criterion": "risk for bleeding",
"requirement": {
"requirement_type": "severity",
"expected_value": "increased"
}
},
{
"exact_snippets": "on active anticoagulation therapy",
"criterion": "active anticoagulation therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "platelets less than 100,000 per mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 100000,
"unit": "per mm^3"
}
}
},
{
"exact_snippets": "PT/PTT greater than 1.5 times the upper normal limit (UNL)",
"criterion": "PT/PTT",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "times the upper normal limit (UNL)"
}
}
},
{
"exact_snippets": "underlying cause is correctable",
"criterion": "underlying cause",
"requirement": {
"requirement_type": "correctability",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "4. Subject s weight exceeding MRI or radiation treatment table tolerance.",
"criterions": [
{
"exact_snippets": "Subject s weight exceeding MRI or radiation treatment table tolerance.",
"criterion": "subject's weight",
"requirement": {
"requirement_type": "tolerance",
"expected_value": "exceeding MRI or radiation treatment table tolerance"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "5. Patients with active urinary tract infections.",
"criterions": [
{
"exact_snippets": "active urinary tract infections",
"criterion": "urinary tract infections",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "active urinary tract infections",
"criterion": "urinary tract infections",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "6. Patients with renal insufficiency with a GFR less than 30, due to the fact that they will not be able to undergo gadolinium enhanced MRI.",
"criterions": [
{
"exact_snippets": "Patients with renal insufficiency",
"criterion": "renal insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "GFR less than 30",
"criterion": "GFR",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 30,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "7. Uncontrolled illness or comorbidity that in the judgment of the PI would preclude participation in the study.",
"criterions": [
{
"exact_snippets": "Uncontrolled illness or comorbidity",
"criterion": "uncontrolled illness or comorbidity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "9. HIV-positive patients are ineligible because HIV is known to increase radiation toxicity and may result in under-dosing or alterations in the treatment plan that would alter the likelihood of local recurrence. Appropriate studies will be undertaken in HIV positive patients when indicated.",
"criterions": [
{
"exact_snippets": "HIV-positive patients are ineligible",
"criterion": "HIV status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "HIV-positive patients are ineligible",
"criterion": "HIV status",
"requirement": {
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"expected_value": true
}
}
}
}
]
}