{
"info": {
"nct_id": "NCT03561220",
"official_title": "A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer",
"inclusion_criteria": "* Diagnosis of adenocarcinoma of the prostate.\n* 30-85 years of age at the time of consent with a life expectancy estimation (LEE) of ≥ 8 years.\n* Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE with or without mpMRI, and clinical stage.\n* Very low-risk, low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.\n* If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones.\n* ECOG/Zubrod Performance Status 0 - 2.\n* Candidate for definitive prostate radiotherapy (either IMRT or proton).\n* If patient is to be treated with IMRT, all treatment must be planned with IMRT; if patient is to be treated with protons, all treatment must be planned with protons (including pelvic nodes if treated).\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 30 Years\nMust have maximum age of 85 Years",
"exclusion_criteria": "* Findings of metastatic disease (nodal or distant, N1 or M1).\n* Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.\n* Prior procedures for treatment of prostate cancer, such as radical or robotic prostatectomy, high-intensity focused ultrasound, cryosurgery, or focal prostatectomy [note that procedures used for benign prostatic hyperplasia symptoms, such as transurethral resection of the prostate (TURP) and GreenLight Laser Therapy, are acceptable].\n* Previous prostate cancer treatment with the exception of ADT according to NCCN guidelines.\n* History of invasive rectal malignancy or other malignancy in the true pelvis (e.g. bladder, rectum, or reproductive organs), regardless of disease-free interval.\n* Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic).\n* Prior pelvic RT for any reason.\n* Documented lack of psychological ability or general health permitting completion of the study requirements and required follow-up.\n* Documented diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent.\n\nIn addition, because the embedded randomized controlled trial compares fractionation schemes, patients who are receiving pelvic node irradiation may not be enrolled on the randomized controlled trial.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Diagnosis of adenocarcinoma of the prostate.",
"criterions": [
{
"exact_snippets": "Diagnosis of adenocarcinoma of the prostate.",
"criterion": "adenocarcinoma of the prostate",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis of adenocarcinoma of the prostate.",
"criterion": "adenocarcinoma of the prostate",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* 30-85 years of age at the time of consent with a life expectancy estimation (LEE) of ≥ 8 years.",
"criterions": [
{
"exact_snippets": "30-85 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 30,
"unit": "years"
},
{
"operator": "<=",
"value": 85,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "life expectancy estimation (LEE) of ≥ 8 years",
"criterion": "life expectancy estimation",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "30-85 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 30,
"unit": "years"
},
{
"operator": "<=",
"value": 85,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "life expectancy estimation (LEE) of ≥ 8 years",
"criterion": "life expectancy estimation",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE with or without mpMRI, and clinical stage.",
"criterions": [
{
"exact_snippets": "Localized prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "localization",
"expected_value": "localized"
}
},
{
"exact_snippets": "confirmed by staging with PSA",
"criterion": "PSA",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... biopsy",
"criterion": "biopsy",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... Gleason score",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... DRE",
"criterion": "DRE",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... mpMRI",
"criterion": "mpMRI",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... clinical stage",
"criterion": "clinical stage",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Localized prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "localization",
"expected_value": "localized"
}
},
{
"or_criteria": [
{
"exact_snippets": "confirmed by staging with PSA",
"criterion": "PSA",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... biopsy",
"criterion": "biopsy",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... Gleason score",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... DRE",
"criterion": "DRE",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "confirmed by staging with ... mpMRI",
"criterion": "mpMRI",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
}
]
}
]
},
{
"exact_snippets": "confirmed by staging with ... clinical stage",
"criterion": "clinical stage",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Very low-risk, low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.",
"criterions": [
{
"exact_snippets": "Very low-risk, low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.",
"criterion": "prostate cancer risk group",
"requirement": {
"requirement_type": "risk level",
"expected_value": [
"very low-risk",
"low-risk",
"intermediate-risk",
"high-risk"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Very low-risk, low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.",
"criterion": "prostate cancer risk group",
"requirement": {
"requirement_type": "risk level",
"expected_value": [
"very low-risk",
"low-risk",
"intermediate-risk",
"high-risk"
]
}
}
]
}
},
{
"identified_line": {
"line": "* If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones.",
"criterions": [
{
"exact_snippets": "high-risk disease",
"criterion": "high-risk disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "nuclear medicine bone imaging must be performed",
"criterion": "nuclear medicine bone imaging",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "absence of overt metastatic disease in bones",
"criterion": "overt metastatic disease in bones",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "high-risk disease",
"criterion": "high-risk disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "nuclear medicine bone imaging must be performed",
"criterion": "nuclear medicine bone imaging",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "absence of overt metastatic disease in bones",
"criterion": "overt metastatic disease in bones",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* ECOG/Zubrod Performance Status 0 - 2.",
"criterions": [
{
"exact_snippets": "ECOG/Zubrod Performance Status 0 - 2",
"criterion": "ECOG/Zubrod Performance Status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG/Zubrod Performance Status 0 - 2",
"criterion": "ECOG/Zubrod Performance Status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Candidate for definitive prostate radiotherapy (either IMRT or proton).",
"criterions": [
{
"exact_snippets": "Candidate for definitive prostate radiotherapy",
"criterion": "prostate radiotherapy candidacy",
"requirement": {
"requirement_type": "candidacy",
"expected_value": true
}
},
{
"exact_snippets": "IMRT",
"criterion": "IMRT",
"requirement": {
"requirement_type": "candidacy",
"expected_value": true
}
},
{
"exact_snippets": "proton",
"criterion": "proton therapy",
"requirement": {
"requirement_type": "candidacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Candidate for definitive prostate radiotherapy",
"criterion": "prostate radiotherapy candidacy",
"requirement": {
"requirement_type": "candidacy",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "IMRT",
"criterion": "IMRT",
"requirement": {
"requirement_type": "candidacy",
"expected_value": true
}
},
{
"exact_snippets": "proton",
"criterion": "proton therapy",
"requirement": {
"requirement_type": "candidacy",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* If patient is to be treated with IMRT, all treatment must be planned with IMRT; if patient is to be treated with protons, all treatment must be planned with protons (including pelvic nodes if treated).",
"criterions": [
{
"exact_snippets": "patient is to be treated with IMRT",
"criterion": "treatment modality",
"requirement": {
"requirement_type": "type",
"expected_value": "IMRT"
}
},
{
"exact_snippets": "patient is to be treated with protons",
"criterion": "treatment modality",
"requirement": {
"requirement_type": "type",
"expected_value": "protons"
}
}
]
},
"logical_structure": {
"xor_criteria": [
{
"condition": {
"exact_snippets": "patient is to be treated with IMRT",
"criterion": "treatment modality",
"requirement": {
"requirement_type": "type",
"expected_value": "IMRT"
}
},
"then_criteria": {
"exact_snippets": "patient is to be treated with IMRT",
"criterion": "treatment planning",
"requirement": {
"requirement_type": "planned with",
"expected_value": "IMRT"
}
},
"else_criteria": null
},
{
"condition": {
"exact_snippets": "patient is to be treated with protons",
"criterion": "treatment modality",
"requirement": {
"requirement_type": "type",
"expected_value": "protons"
}
},
"then_criteria": {
"exact_snippets": "patient is to be treated with protons",
"criterion": "treatment planning",
"requirement": {
"requirement_type": "planned with",
"expected_value": "protons"
}
},
"else_criteria": null
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 30 Years",
"criterions": [
{
"exact_snippets": "minimum age of 30 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 30 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 85 Years",
"criterions": [
{
"exact_snippets": "maximum age of 85 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 85,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 85 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 85,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Findings of metastatic disease (nodal or distant, N1 or M1).",
"criterions": [
{
"exact_snippets": "Findings of metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "nodal",
"criterion": "nodal involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "distant",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "N1",
"criterion": "N1 stage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "M1",
"criterion": "M1 stage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Findings of metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "nodal",
"criterion": "nodal involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Findings of metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "distant",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "N1",
"criterion": "N1 stage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "M1",
"criterion": "M1 stage",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.",
"criterions": [
{
"exact_snippets": "Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "risk level",
"expected_value": "very high-risk"
}
},
{
"exact_snippets": "Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "guideline",
"expected_value": "NCCN Prostate Cancer Risk Group Guidelines"
}
},
{
"exact_snippets": "Very high-risk prostate cancer based on ... Joint AUA/ASTRO/SUO Guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "risk level",
"expected_value": "very high-risk"
}
},
{
"exact_snippets": "Very high-risk prostate cancer based on ... Joint AUA/ASTRO/SUO Guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "guideline",
"expected_value": "Joint AUA/ASTRO/SUO Guidelines"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "risk level",
"expected_value": "very high-risk"
}
},
{
"exact_snippets": "Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "guideline",
"expected_value": "NCCN Prostate Cancer Risk Group Guidelines"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Very high-risk prostate cancer based on ... Joint AUA/ASTRO/SUO Guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "risk level",
"expected_value": "very high-risk"
}
},
{
"exact_snippets": "Very high-risk prostate cancer based on ... Joint AUA/ASTRO/SUO Guidelines",
"criterion": "prostate cancer risk",
"requirement": {
"requirement_type": "guideline",
"expected_value": "Joint AUA/ASTRO/SUO Guidelines"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Prior procedures for treatment of prostate cancer, such as radical or robotic prostatectomy, high-intensity focused ultrasound, cryosurgery, or focal prostatectomy [note that procedures used for benign prostatic hyperplasia symptoms, such as transurethral resection of the prostate (TURP) and GreenLight Laser Therapy, are acceptable].",
"criterions": [
{
"exact_snippets": "Prior procedures for treatment of prostate cancer, such as radical or robotic prostatectomy, high-intensity focused ultrasound, cryosurgery, or focal prostatectomy",
"criterion": "prior procedures for treatment of prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "procedures used for benign prostatic hyperplasia symptoms, such as transurethral resection of the prostate (TURP) and GreenLight Laser Therapy, are acceptable",
"criterion": "procedures for benign prostatic hyperplasia",
"requirement": {
"requirement_type": "acceptability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Prior procedures for treatment of prostate cancer, such as radical or robotic prostatectomy, high-intensity focused ultrasound, cryosurgery, or focal prostatectomy",
"criterion": "prior procedures for treatment of prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"exact_snippets": "procedures used for benign prostatic hyperplasia symptoms, such as transurethral resection of the prostate (TURP) and GreenLight Laser Therapy, are acceptable",
"criterion": "procedures for benign prostatic hyperplasia",
"requirement": {
"requirement_type": "acceptability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* History of invasive rectal malignancy or other malignancy in the true pelvis (e.g. bladder, rectum, or reproductive organs), regardless of disease-free interval.",
"criterions": [
{
"exact_snippets": "History of invasive rectal malignancy",
"criterion": "invasive rectal malignancy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "other malignancy in the true pelvis (e.g. bladder, rectum, or reproductive organs)",
"criterion": "malignancy in the true pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of invasive rectal malignancy",
"criterion": "invasive rectal malignancy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "other malignancy in the true pelvis (e.g. bladder, rectum, or reproductive organs)",
"criterion": "malignancy in the true pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic).",
"criterions": [
{
"exact_snippets": "Active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "patients requiring medical interventions",
"criterion": "medical interventions",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "patients ... who are symptomatic",
"criterion": "symptoms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"or_criteria": [
{
"exact_snippets": "patients requiring medical interventions",
"criterion": "medical interventions",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "patients ... who are symptomatic",
"criterion": "symptoms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Prior pelvic RT for any reason.",
"criterions": [
{
"exact_snippets": "Prior pelvic RT",
"criterion": "pelvic RT",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior pelvic RT",
"criterion": "pelvic RT",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Documented lack of psychological ability or general health permitting completion of the study requirements and required follow-up.",
"criterions": [
{
"exact_snippets": "Documented lack of psychological ability",
"criterion": "psychological ability",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "general health permitting completion of the study requirements and required follow-up",
"criterion": "general health",
"requirement": {
"requirement_type": "sufficiency",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Documented lack of psychological ability",
"criterion": "psychological ability",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"not_criteria": {
"exact_snippets": "general health permitting completion of the study requirements and required follow-up",
"criterion": "general health",
"requirement": {
"requirement_type": "sufficiency",
"expected_value": true
}
}
}
]
}
},
{
"identified_line": {
"line": "* Documented diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent.",
"criterions": [
{
"exact_snippets": "Documented diminished capacity to understand the risks and benefits of participation in research",
"criterion": "capacity to understand risks and benefits",
"requirement": {
"requirement_type": "severity",
"expected_value": "diminished"
}
},
{
"exact_snippets": "autonomously provide informed consent",
"criterion": "ability to provide informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Documented diminished capacity to understand the risks and benefits of participation in research",
"criterion": "capacity to understand risks and benefits",
"requirement": {
"requirement_type": "severity",
"expected_value": "diminished"
}
},
{
"exact_snippets": "autonomously provide informed consent",
"criterion": "ability to provide informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "In addition, because the embedded randomized controlled trial compares fractionation schemes, patients who are receiving pelvic node irradiation may not be enrolled on the randomized controlled trial.",
"criterions": [
{
"exact_snippets": "patients who are receiving pelvic node irradiation may not be enrolled",
"criterion": "pelvic node irradiation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "patients who are receiving pelvic node irradiation may not be enrolled",
"criterion": "pelvic node irradiation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Previous prostate cancer treatment with the exception of ADT according to NCCN guidelines.",
"criterions": [
{
"exact_snippets": "Previous prostate cancer treatment",
"criterion": "previous prostate cancer treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "exception of ADT according to NCCN guidelines",
"criterion": "ADT according to NCCN guidelines",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Previous prostate cancer treatment",
"criterion": "previous prostate cancer treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "exception of ADT according to NCCN guidelines",
"criterion": "ADT according to NCCN guidelines",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
]
}
}
]
}
}
],
"failed_miscellaneous": []
}