[96a5a0]: / output / allTrials / logical / NCT04610372_logical.json

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{
"info": {
"nct_id": "NCT04610372",
"official_title": "Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment",
"inclusion_criteria": "* Able to provide informed consent\n* European Cooperative Oncology Group performance status 0 to 2\n* Medically fit for all protocol treatment and follow-up\n* Histologically confirmed adenocarcinoma of the prostate\n* Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases\n* No prior therapy for prostate cancer apart from androgen deprivation\n* Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization\n* If used, anti-androgens must have started within 26 weeks of randomization\n* Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization (History and physical examination, PSA)\n* Able to complete the necessary investigations priOr to start of Radiotherapy (Transrectal ultrasound-guided biopsy, CT chest, abdomen & pelvis or MRI abdomen and pelvis, and Bone scan)\n* Planned for long-term androgen deprivation therapy\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* High metastatic burden defined as 5 or more bone metastases or visceral metastases\n* Abnormal liver function\n* Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation\n* Medically unfit for anesthesia\n* International Prostate Symptom Score (IPSS) greater than 20\n* Restrictive flow pattern with peak flow rate less than10 mL per second or post-void residual greater than 25 per cent of voided volume (when uroflowmetry available)\n* Prostate volume greater than 60cc after maximal cytoreduction\n* Pubic arch interference\n* Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Able to provide informed consent",
"criterions": [
{
"exact_snippets": "Able to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* European Cooperative Oncology Group performance status 0 to 2",
"criterions": [
{
"exact_snippets": "European Cooperative Oncology Group performance status 0 to 2",
"criterion": "European Cooperative Oncology Group 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": "European Cooperative Oncology Group performance status 0 to 2",
"criterion": "European Cooperative Oncology Group performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Medically fit for all protocol treatment and follow-up",
"criterions": [
{
"exact_snippets": "Medically fit for all protocol treatment and follow-up",
"criterion": "medical fitness",
"requirement": {
"requirement_type": "fitness for treatment and follow-up",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Medically fit for all protocol treatment and follow-up",
"criterion": "medical fitness",
"requirement": {
"requirement_type": "fitness for treatment and follow-up",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Histologically confirmed adenocarcinoma of the prostate",
"criterions": [
{
"exact_snippets": "Histologically confirmed adenocarcinoma of the prostate",
"criterion": "adenocarcinoma of the prostate",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically confirmed adenocarcinoma of the prostate",
"criterion": "adenocarcinoma of the prostate",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
}
},
{
"identified_line": {
"line": "* Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases",
"criterions": [
{
"exact_snippets": "Newly diagnosed",
"criterion": "diagnosis status",
"requirement": {
"requirement_type": "status",
"expected_value": "newly diagnosed"
}
},
{
"exact_snippets": "any Tumor stage",
"criterion": "tumor stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "any"
}
},
{
"exact_snippets": "any Nodal stage",
"criterion": "nodal stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "any"
}
},
{
"exact_snippets": "oligo metastases",
"criterion": "metastases",
"requirement": {
"requirement_type": "type",
"expected_value": "oligo"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Newly diagnosed",
"criterion": "diagnosis status",
"requirement": {
"requirement_type": "status",
"expected_value": "newly diagnosed"
}
},
{
"exact_snippets": "any Tumor stage",
"criterion": "tumor stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "any"
}
},
{
"exact_snippets": "any Nodal stage",
"criterion": "nodal stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "any"
}
},
{
"exact_snippets": "oligo metastases",
"criterion": "metastases",
"requirement": {
"requirement_type": "type",
"expected_value": "oligo"
}
}
]
}
},
{
"identified_line": {
"line": "* No prior therapy for prostate cancer apart from androgen deprivation",
"criterions": [
{
"exact_snippets": "No prior therapy for prostate cancer",
"criterion": "prior therapy for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "apart from androgen deprivation",
"criterion": "androgen deprivation therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "No prior therapy for prostate cancer",
"criterion": "prior therapy for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"exact_snippets": "apart from androgen deprivation",
"criterion": "androgen deprivation therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization",
"criterions": [
{
"exact_snippets": "Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization",
"criterion": "Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists",
"requirement": {
"requirement_type": "start time",
"expected_value": {
"operator": "<=",
"value": 24,
"unit": "weeks from randomization"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization",
"criterion": "Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists",
"requirement": {
"requirement_type": "start time",
"expected_value": {
"operator": "<=",
"value": 24,
"unit": "weeks from randomization"
}
}
}
]
}
},
{
"identified_line": {
"line": "* If used, anti-androgens must have started within 26 weeks of randomization",
"criterions": [
{
"exact_snippets": "anti-androgens must have started within 26 weeks of randomization",
"criterion": "anti-androgens",
"requirement": {
"requirement_type": "start time relative to randomization",
"expected_value": {
"operator": "<=",
"value": 26,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "anti-androgens must have started within 26 weeks of randomization",
"criterion": "anti-androgens",
"requirement": {
"requirement_type": "start time relative to randomization",
"expected_value": {
"operator": "<=",
"value": 26,
"unit": "weeks"
}
}
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Able to complete the necessary investigations priOr to start of Radiotherapy (Transrectal ultrasound-guided biopsy, CT chest, abdomen & pelvis or MRI abdomen and pelvis, and Bone scan)",
"criterions": [
{
"exact_snippets": "Able to complete the necessary investigations ... Transrectal ultrasound-guided biopsy",
"criterion": "transrectal ultrasound-guided biopsy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "Able to complete the necessary investigations ... CT chest, abdomen & pelvis",
"criterion": "CT chest, abdomen & pelvis",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "Able to complete the necessary investigations ... MRI abdomen and pelvis",
"criterion": "MRI abdomen and pelvis",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "Able to complete the necessary investigations ... Bone scan",
"criterion": "bone scan",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Able to complete the necessary investigations ... Transrectal ultrasound-guided biopsy",
"criterion": "transrectal ultrasound-guided biopsy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "Able to complete the necessary investigations ... CT chest, abdomen & pelvis",
"criterion": "CT chest, abdomen & pelvis",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "Able to complete the necessary investigations ... Bone scan",
"criterion": "bone scan",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Able to complete the necessary investigations ... MRI abdomen and pelvis",
"criterion": "MRI abdomen and pelvis",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "Able to complete the necessary investigations ... Bone scan",
"criterion": "bone scan",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Planned for long-term androgen deprivation therapy",
"criterions": [
{
"exact_snippets": "Planned for long-term androgen deprivation therapy",
"criterion": "androgen deprivation therapy",
"requirement": {
"requirement_type": "planned duration",
"expected_value": "long-term"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Planned for long-term androgen deprivation therapy",
"criterion": "androgen deprivation therapy",
"requirement": {
"requirement_type": "planned duration",
"expected_value": "long-term"
}
}
]
}
},
{
"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": "value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "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"
}
}
}
]
},
"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": "* High metastatic burden defined as 5 or more bone metastases or visceral metastases",
"criterions": [
{
"exact_snippets": "High metastatic burden defined as 5 or more bone metastases",
"criterion": "bone metastases",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "High metastatic burden defined as ... visceral metastases",
"criterion": "visceral metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "High metastatic burden defined as 5 or more bone metastases",
"criterion": "bone metastases",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "High metastatic burden defined as ... visceral metastases",
"criterion": "visceral metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Abnormal liver function",
"criterions": [
{
"exact_snippets": "Abnormal liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "status",
"expected_value": "abnormal"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Abnormal liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "status",
"expected_value": "abnormal"
}
}
}
},
{
"identified_line": {
"line": "* Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation",
"criterions": [
{
"exact_snippets": "Contraindications to EBRT such as active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Contraindications to EBRT such as ... previous pelvic radiation",
"criterion": "previous pelvic radiation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Contraindications to EBRT such as active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Contraindications to EBRT such as ... previous pelvic radiation",
"criterion": "previous pelvic radiation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Medically unfit for anesthesia",
"criterions": [
{
"exact_snippets": "Medically unfit for anesthesia",
"criterion": "fitness for anesthesia",
"requirement": {
"requirement_type": "medical fitness",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Medically unfit for anesthesia",
"criterion": "fitness for anesthesia",
"requirement": {
"requirement_type": "medical fitness",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* International Prostate Symptom Score (IPSS) greater than 20",
"criterions": [
{
"exact_snippets": "International Prostate Symptom Score (IPSS) greater than 20",
"criterion": "International Prostate Symptom Score (IPSS)",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 20,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "International Prostate Symptom Score (IPSS) greater than 20",
"criterion": "International Prostate Symptom Score (IPSS)",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 20,
"unit": "N/A"
}
}
}
}
},
{
"identified_line": {
"line": "* Restrictive flow pattern with peak flow rate less than10 mL per second or post-void residual greater than 25 per cent of voided volume (when uroflowmetry available)",
"criterions": [
{
"exact_snippets": "Restrictive flow pattern",
"criterion": "flow pattern",
"requirement": {
"requirement_type": "type",
"expected_value": "restrictive"
}
},
{
"exact_snippets": "peak flow rate less than10 mL per second",
"criterion": "peak flow rate",
"requirement": {
"requirement_type": "rate",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "mL per second"
}
}
},
{
"exact_snippets": "post-void residual greater than 25 per cent of voided volume",
"criterion": "post-void residual",
"requirement": {
"requirement_type": "volume",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "per cent of voided volume"
}
}
},
{
"exact_snippets": "when uroflowmetry available",
"criterion": "uroflowmetry",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "when uroflowmetry available",
"criterion": "uroflowmetry",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
"then_criteria": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Restrictive flow pattern",
"criterion": "flow pattern",
"requirement": {
"requirement_type": "type",
"expected_value": "restrictive"
}
},
{
"exact_snippets": "peak flow rate less than10 mL per second",
"criterion": "peak flow rate",
"requirement": {
"requirement_type": "rate",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "mL per second"
}
}
}
]
},
{
"exact_snippets": "post-void residual greater than 25 per cent of voided volume",
"criterion": "post-void residual",
"requirement": {
"requirement_type": "volume",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "per cent of voided volume"
}
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Prostate volume greater than 60cc after maximal cytoreduction",
"criterions": [
{
"exact_snippets": "Prostate volume greater than 60cc",
"criterion": "prostate volume",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "cc"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Prostate volume greater than 60cc",
"criterion": "prostate volume",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "cc"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Pubic arch interference",
"criterions": [
{
"exact_snippets": "Pubic arch interference",
"criterion": "pubic arch interference",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pubic arch interference",
"criterion": "pubic arch interference",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy",
"criterions": [
{
"exact_snippets": "Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy",
"criterion": "transurethral resection of prostate (TURP)",
"requirement": {
"requirement_type": "time since procedure",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy",
"criterion": "transurethral resection of prostate (TURP)",
"requirement": {
"requirement_type": "time since procedure",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "weeks"
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization (History and physical examination, PSA)",
"criterions": [
{
"exact_snippets": "Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization",
"criterion": "completion of necessary investigations",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "prior to and within 12 weeks of starting ADT or randomization"
}
},
{
"exact_snippets": "History and physical examination",
"criterion": "history and physical examination",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "PSA",
"criterion": "PSA",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization",
"criterion": "completion of necessary investigations",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "prior to and within 12 weeks of starting ADT"
}
},
{
"exact_snippets": "Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization",
"criterion": "completion of necessary investigations",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "prior to and within 12 weeks of randomization"
}
}
]
},
{
"exact_snippets": "History and physical examination",
"criterion": "history and physical examination",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
{
"exact_snippets": "PSA",
"criterion": "PSA",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}