{
"info": {
"nct_id": "NCT01087580",
"official_title": "A Randomized Phase-II Pilot Trial of Docetaxel and Prednisone Versus Radiation Therapy Plus Docetaxel and Prednisone in Patients With Nonmetastatic and Oligometastatic Castrate Resistant Prostate Cancer",
"inclusion_criteria": "* Participants must have a diagnosis of castrate resistant prostate cancer.\n* Participants must be 18 years old or older.\n* Biopsy of tissue from the prostate or enlarged lymph nodes may be required.\n* Patients must sign study specific informed consent prior to study entry.\n* Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Participants cannot have prior chemotherapy for prostate cancer.\n* Participants cannot have prior radiation therapy to the pelvis.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Participants must have a diagnosis of castrate resistant prostate cancer.",
"criterions": [
{
"exact_snippets": "diagnosis of castrate resistant prostate cancer",
"criterion": "castrate resistant prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "diagnosis of castrate resistant prostate cancer",
"criterion": "castrate resistant prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Participants must be 18 years old or older.",
"criterions": [
{
"exact_snippets": "Participants must be 18 years old or older.",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Participants must be 18 years old or older.",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
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}
}
]
}
},
{
"identified_line": {
"line": "* Biopsy of tissue from the prostate or enlarged lymph nodes may be required.",
"criterions": [
{
"exact_snippets": "Biopsy of tissue from the prostate ... may be required.",
"criterion": "biopsy of prostate tissue",
"requirement": {
"requirement_type": "requirement",
"expected_value": "may be required"
}
},
{
"exact_snippets": "Biopsy of tissue from ... enlarged lymph nodes may be required.",
"criterion": "biopsy of enlarged lymph nodes",
"requirement": {
"requirement_type": "requirement",
"expected_value": "may be required"
}
}
]
},
"logical_structure": {
"or_criteria": [
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"exact_snippets": "Biopsy of tissue from the prostate ... may be required.",
"criterion": "biopsy of prostate tissue",
"requirement": {
"requirement_type": "requirement",
"expected_value": "may be required"
}
},
{
"exact_snippets": "Biopsy of tissue from ... enlarged lymph nodes may be required.",
"criterion": "biopsy of enlarged lymph nodes",
"requirement": {
"requirement_type": "requirement",
"expected_value": "may be required"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must sign study specific informed consent prior to study entry.",
"criterions": [
{
"exact_snippets": "Patients must sign study specific informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients must sign study specific informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.",
"criterions": [
{
"exact_snippets": "Men of child-producing potential",
"criterion": "child-producing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must be willing to consent to use effective contraception",
"criterion": "willingness to use contraception",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "while on treatment and for at least 3 months afterwards",
"criterion": "duration of contraception use",
"requirement": {
"requirement_type": "duration",
"expected_value": "while on treatment and for at least 3 months afterwards"
}
}
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},
"logical_structure": {
"and_criteria": [
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"and_criteria": [
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"exact_snippets": "Men of child-producing potential",
"criterion": "child-producing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must be willing to consent to use effective contraception",
"criterion": "willingness to use contraception",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "while on treatment and for at least 3 months afterwards",
"criterion": "duration of contraception use",
"requirement": {
"requirement_type": "duration",
"expected_value": "while on treatment and for at least 3 months afterwards"
}
}
]
}
},
{
"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": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
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},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Participants cannot have prior chemotherapy for prostate cancer.",
"criterions": [
{
"exact_snippets": "Participants cannot have prior chemotherapy for prostate cancer.",
"criterion": "prior chemotherapy for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Participants cannot have prior chemotherapy for prostate cancer.",
"criterion": "prior chemotherapy for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Participants cannot have prior radiation therapy to the pelvis.",
"criterions": [
{
"exact_snippets": "prior radiation therapy to the pelvis",
"criterion": "prior radiation therapy to the pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "prior radiation therapy to the pelvis",
"criterion": "prior radiation therapy to the pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}