{
"info": {
"nct_id": "NCT02225262",
"official_title": "Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution",
"inclusion_criteria": "* Male Age ≥ 21\n* Histologically proven prostate adenocarcinoma\n* Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)\n* PSA ≤ 20 ng/ml\n* Prostate volume ≤ 100 cc\n\nPatients belonging in one of the following risk groups:\n\n* Low:\n\n * CS T1b-T2a and Gleason 2-6 and PSA ≤ 10\n* Intermediate:\n\n * CS T2b and Gleason 2-6 and PSA ≤ 10, OR\n * CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 21 Years",
"exclusion_criteria": "* Any histology other than adenocarcinoma\n* Age < 21\n* KPS <= 40 <70\n* ECOG Performance Status ≥ 2\n* Patient weight >350 lbs. (table limitation)\n* Prior XRT to prostate or lower pelvis\n* Prior surgery or cryotherapy to prostate\n* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion\n* Chemotherapy for a malignancy in the last 5 years\n* History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years\n* Hormone ablation for 2 months prior to enrollment, or during treatment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Male Age ≥ 21",
"criterions": [
{
"exact_snippets": "Male",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"exact_snippets": "Age ≥ 21",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Male",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
},
{
"exact_snippets": "Age ≥ 21",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histologically proven prostate adenocarcinoma",
"criterions": [
{
"exact_snippets": "Histologically proven prostate adenocarcinoma",
"criterion": "prostate adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically proven"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically proven prostate adenocarcinoma",
"criterion": "prostate adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically proven"
}
}
]
}
},
{
"identified_line": {
"line": "* Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)",
"criterions": [
{
"exact_snippets": "Clinical stage T1b-T2b",
"criterion": "clinical stage T",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "b"
},
{
"operator": "<=",
"value": 2,
"unit": "b"
}
]
}
}
},
{
"exact_snippets": "N0-Nx",
"criterion": "clinical stage N",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": ""
},
{
"operator": "<=",
"value": 0,
"unit": "x"
}
]
}
}
},
{
"exact_snippets": "M0-Mx",
"criterion": "clinical stage M",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": ""
},
{
"operator": "<=",
"value": 0,
"unit": "x"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Clinical stage T1b-T2b",
"criterion": "clinical stage T",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "b"
},
{
"operator": "<=",
"value": 2,
"unit": "b"
}
]
}
}
},
{
"exact_snippets": "N0-Nx",
"criterion": "clinical stage N",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": ""
},
{
"operator": "<=",
"value": 0,
"unit": "x"
}
]
}
}
},
{
"exact_snippets": "M0-Mx",
"criterion": "clinical stage M",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": ""
},
{
"operator": "<=",
"value": 0,
"unit": "x"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Patients belonging in one of the following risk groups:",
"criterions": [
{
"exact_snippets": "Patients belonging in one of the following risk groups",
"criterion": "risk group",
"requirement": {
"requirement_type": "membership",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Patients belonging in one of the following risk groups",
"criterion": "risk group",
"requirement": {
"requirement_type": "membership",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Low:",
"criterions": [
{
"exact_snippets": "Low",
"criterion": "risk level",
"requirement": {
"requirement_type": "severity",
"expected_value": "low"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Low",
"criterion": "risk level",
"requirement": {
"requirement_type": "severity",
"expected_value": "low"
}
}
]
}
},
{
"identified_line": {
"line": "* CS T1b-T2a and Gleason 2-6 and PSA ≤ 10",
"criterions": [
{
"exact_snippets": "CS T1b-T2a",
"criterion": "clinical stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1.1,
"unit": "T"
},
{
"operator": "<=",
"value": 2.1,
"unit": "T"
}
]
}
}
},
{
"exact_snippets": "Gleason 2-6",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 6,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "PSA ≤ 10",
"criterion": "PSA level",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "CS T1b-T2a",
"criterion": "clinical stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1.1,
"unit": "T"
},
{
"operator": "<=",
"value": 2.1,
"unit": "T"
}
]
}
}
},
{
"exact_snippets": "Gleason 2-6",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 6,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "PSA ≤ 10",
"criterion": "PSA level",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Intermediate:",
"criterions": [
{
"exact_snippets": "Intermediate",
"criterion": "disease stage",
"requirement": {
"requirement_type": "severity",
"expected_value": "Intermediate"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Intermediate",
"criterion": "disease stage",
"requirement": {
"requirement_type": "severity",
"expected_value": "Intermediate"
}
}
]
}
},
{
"identified_line": {
"line": "* CS T2b and Gleason 2-6 and PSA ≤ 10, OR",
"criterions": [
{
"exact_snippets": "CS T2b",
"criterion": "clinical stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "T2b"
}
},
{
"exact_snippets": "Gleason 2-6",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 6,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "PSA ≤ 10",
"criterion": "PSA level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "CS T2b",
"criterion": "clinical stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "T2b"
}
},
{
"exact_snippets": "Gleason 2-6",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 6,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "PSA ≤ 10",
"criterion": "PSA level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "N/A"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml",
"criterions": [
{
"exact_snippets": "CS T1b-T2b",
"criterion": "clinical stage",
"requirement": {
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"expected_value": {
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{
"operator": ">=",
"value": 1,
"unit": "b"
},
{
"operator": "<=",
"value": 2,
"unit": "b"
}
]
}
}
},
{
"exact_snippets": "Gleason 2-6",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 6,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "PSA ≤ 20 ng/ml",
"criterion": "PSA level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 20,
"unit": "ng/ml"
}
}
},
{
"exact_snippets": "Gleason 7",
"criterion": "Gleason score",
"requirement": {
"requirement_type": "exact",
"expected_value": "7"
}
},
{
"exact_snippets": "PSA ≤ 10 ng/ml",
"criterion": "PSA level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "ng/ml"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "CS T1b-T2b",
"criterion": "clinical stage",
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{
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"value": 1,
"unit": "b"
},
{
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"unit": "b"
}
]
}
}
},
{
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{
"operator": ">=",
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"unit": "N/A"
},
{
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"unit": "N/A"
}
]
}
}
}
]
},
{
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"criterion": "PSA level",
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"operator": "<=",
"value": 20,
"unit": "ng/ml"
}
}
}
]
},
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "CS T1b-T2b",
"criterion": "clinical stage",
"requirement": {
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"expected_value": {
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{
"operator": ">=",
"value": 1,
"unit": "b"
},
{
"operator": "<=",
"value": 2,
"unit": "b"
}
]
}
}
},
{
"exact_snippets": "Gleason 7",
"criterion": "Gleason score",
"requirement": {
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"expected_value": "7"
}
}
]
},
{
"exact_snippets": "PSA ≤ 10 ng/ml",
"criterion": "PSA level",
"requirement": {
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"operator": "<=",
"value": 10,
"unit": "ng/ml"
}
}
}
]
}
]
}
},
{
"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": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
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"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 21 Years",
"criterions": [
{
"exact_snippets": "minimum age of 21 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 21,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 21 Years",
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"requirement": {
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"operator": ">=",
"value": 21,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Any histology other than adenocarcinoma",
"criterions": [
{
"exact_snippets": "histology other than adenocarcinoma",
"criterion": "histology",
"requirement": {
"requirement_type": "type",
"expected_value": {
"operator": "!=",
"value": 1,
"unit": "adenocarcinoma"
}
}
}
]
},
"logical_structure": {
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"criterion": "histology",
"requirement": {
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"operator": "!=",
"value": 1,
"unit": "adenocarcinoma"
}
}
}
}
},
{
"identified_line": {
"line": "* Age < 21",
"criterions": [
{
"exact_snippets": "Age < 21",
"criterion": "age",
"requirement": {
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"operator": "<",
"value": 21,
"unit": "years"
}
}
}
]
},
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{
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"criterion": "age",
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"operator": "<",
"value": 21,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* KPS <= 40 <70",
"criterions": [
{
"exact_snippets": "KPS <= 40 <70",
"criterion": "Karnofsky Performance Status (KPS)",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 40,
"unit": "N/A"
},
{
"operator": "<",
"value": 70,
"unit": "N/A"
}
]
}
}
}
]
},
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{
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"operator": "<=",
"value": 40,
"unit": "N/A"
},
{
"operator": "<",
"value": 70,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* ECOG Performance Status ≥ 2",
"criterions": [
{
"exact_snippets": "ECOG Performance Status ≥ 2",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
}
},
{
"identified_line": {
"line": "* Patient weight >350 lbs. (table limitation)",
"criterions": [
{
"exact_snippets": "Patient weight >350 lbs.",
"criterion": "weight",
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"expected_value": {
"operator": ">",
"value": 350,
"unit": "lbs"
}
}
}
]
},
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{
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"criterion": "weight",
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"operator": ">",
"value": 350,
"unit": "lbs"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Prior XRT to prostate or lower pelvis",
"criterions": [
{
"exact_snippets": "Prior XRT to prostate",
"criterion": "prior XRT to prostate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Prior XRT to ... lower pelvis",
"criterion": "prior XRT to lower pelvis",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Prior XRT to prostate",
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}
},
{
"exact_snippets": "Prior XRT to ... lower pelvis",
"criterion": "prior XRT to lower pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Prior surgery or cryotherapy to prostate",
"criterions": [
{
"exact_snippets": "Prior surgery ... to prostate",
"criterion": "prostate surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Prior ... cryotherapy to prostate",
"criterion": "prostate cryotherapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Prior surgery ... to prostate",
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"expected_value": true
}
},
{
"exact_snippets": "Prior ... cryotherapy to prostate",
"criterion": "prostate cryotherapy",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion",
"criterions": [
{
"exact_snippets": "Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery",
"criterion": "implanted hardware or other material",
"requirement": {
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"expected_value": "prohibit appropriate treatment planning or treatment delivery"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery",
"criterion": "implanted hardware or other material",
"requirement": {
"requirement_type": "impact on treatment",
"expected_value": "prohibit appropriate treatment planning or treatment delivery"
}
},
{
"exact_snippets": "in the investigator's opinion",
"criterion": "investigator's opinion",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Chemotherapy for a malignancy in the last 5 years",
"criterions": [
{
"exact_snippets": "Chemotherapy for a malignancy in the last 5 years",
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},
{
"identified_line": {
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{
"exact_snippets": "History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years",
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{
"exact_snippets": "History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years",
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"operator": "<=",
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{
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"exact_snippets": "History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years",
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{
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{
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},
{
"identified_line": {
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{
"exact_snippets": "Hormone ablation ... during treatment",
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"and_criteria": [
{
"exact_snippets": "Hormone ablation for 2 months prior to enrollment",
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{
"exact_snippets": "Hormone ablation for 2 months prior to enrollment",
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{
"exact_snippets": "Hormone ablation ... during treatment",
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],
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"exact_snippets": "PSA \u0010 20 ng/ml",
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},
{
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}