ID

36899

Description

Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT02454543

Link

https://clinicaltrials.gov/show/NCT02454543

Keywords

Versions (1)
  1. 6/19/19 6/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02454543

English

Eligibility Prostate Cancer NCT02454543

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
newly diagnosed, histologically confirmed adenocarcinoma of the prostate within the last 3 months prior to randomization
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
at least one and at most three bone metastases in imaging studies (bone scintigraphy, mri, pet-ct) and no evidence of visceral metastasis. patients with evidence of lymph node metastasis (n1) are allowed
Description

Secondary malignant neoplasm of bone Quantity Imaging studies | Bone scintigraphy | MRI | PET/CT scan | Neoplasm Metastasis Visceral Absent | Secondary malignant neoplasm of lymph node

Data type

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1881134
UMLS CUI [2]
C3889015
UMLS CUI [3]
C0024485
UMLS CUI [4]
C1699633
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0442045
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C0686619
prostate-specific antigen (psa) <150 ng / ml at diagnosis (without systemic therapy)
Description

Prostate specific antigen measurement | Systemic therapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0332197
asymptomatic or mild symptomatic disease
Description

Asymptomatic Disease | Disease Symptomatic Mild

Data type

boolean

Alias
UMLS CUI [1]
C2936329
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C2945599
local respectable tumor stage defined as clinical stage ≤ t3 based on the results of the digital rectal examination or pelvic imaging
Description

Local cancer Resectable TNM clinical staging | Digital Rectal Examination | Imaging of pelvis

Data type

boolean

Alias
UMLS CUI [1,1]
C0796563
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C1384593
UMLS CUI [3]
C3703842
eastern cooperative oncology group (ecog) performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 18 - ≤ 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to radical prostatectomy (local not resectable disease, increased anesthetic risk with co-morbidity)
Description

Medical contraindication Radical prostatectomy | Local disease unresectable | Comorbidity At risk of complication of anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0194810
UMLS CUI [2,1]
C0277565
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C4544425
detection of more than 3 bone metastases
Description

Secondary malignant neoplasm of bone Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C1265611
previous radiation therapy of symptomatic bone metastases
Description

Prior radiation therapy Secondary malignant neoplasm of bone Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0153690
UMLS CUI [1,3]
C0231220
pain management with opioid analgesics
Description

Pain management | Analgesics, Opioid

Data type

boolean

Alias
UMLS CUI [1]
C0002766
UMLS CUI [2]
C0002772
detection of visceral metastases or brain metastases
Description

Neoplasm Metastasis Visceral | Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
UMLS CUI [2]
C0220650
neuroendocrine and / or small cell differentiation in histology of the biopsy
Description

Neuroendocrine Differentiation | Cell Small Differentiation | Histology Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C1709218
UMLS CUI [2,1]
C0007634
UMLS CUI [2,2]
C0700321
UMLS CUI [2,3]
C0007589
UMLS CUI [3,1]
C0344441
UMLS CUI [3,2]
C0005558
charlson comorbidity index > 2
Description

Charlson Comorbidity Index

Data type

boolean

Alias
UMLS CUI [1]
C4546361
ecog performance score > 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
myocardial infarction or stroke within the last 6 months
Description

Myocardial Infarction | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
existing major cardiovascular (grade iii - iv according to nyha), pulmonary (po2 <60 mmhg), renal, hepatic or hematopoietic (eg, severe bone marrow aplasia) disease
Description

Cardiovascular Disease Major New York Heart Association Classification | Lung disease | PO2 measurement | Kidney Disease | Liver disease | Hematological Disease | Bone marrow aplasia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0024115
UMLS CUI [3]
C1283004
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0018939
UMLS CUI [7,1]
C1368107
UMLS CUI [7,2]
C0205082
severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution
Description

Mental Disorders, Severe | Institutionalized Persons

Data type

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2]
C0376326
simultaneous participation in another clinical trial with interventional character of the metastatic prostate cancer
Description

Study Subject Participation Status | Interventional Study | Metastatic Prostate Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3]
C0936223
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Similar models

Eligibility Prostate Cancer NCT02454543

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
newly diagnosed, histologically confirmed adenocarcinoma of the prostate within the last 3 months prior to randomization
boolean
C0007112 (UMLS CUI [1])
Secondary malignant neoplasm of bone Quantity Imaging studies | Bone scintigraphy | MRI | PET/CT scan | Neoplasm Metastasis Visceral Absent | Secondary malignant neoplasm of lymph node
Item
at least one and at most three bone metastases in imaging studies (bone scintigraphy, mri, pet-ct) and no evidence of visceral metastasis. patients with evidence of lymph node metastasis (n1) are allowed
boolean
C0153690 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1881134 (UMLS CUI [1,3])
C3889015 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C1699633 (UMLS CUI [4])
C0027627 (UMLS CUI [5,1])
C0442045 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0686619 (UMLS CUI [6])
Prostate specific antigen measurement | Systemic therapy Absent
Item
prostate-specific antigen (psa) <150 ng / ml at diagnosis (without systemic therapy)
boolean
C0201544 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Asymptomatic Disease | Disease Symptomatic Mild
Item
asymptomatic or mild symptomatic disease
boolean
C2936329 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C2945599 (UMLS CUI [2,3])
Local cancer Resectable TNM clinical staging | Digital Rectal Examination | Imaging of pelvis
Item
local respectable tumor stage defined as clinical stage ≤ t3 based on the results of the digital rectal examination or pelvic imaging
boolean
C0796563 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1384593 (UMLS CUI [2])
C3703842 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥ 18 - ≤ 75 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Radical prostatectomy | Local disease unresectable | Comorbidity At risk of complication of anesthesia
Item
contraindications to radical prostatectomy (local not resectable disease, increased anesthetic risk with co-morbidity)
boolean
C1301624 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
C0277565 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C4544425 (UMLS CUI [3,2])
Secondary malignant neoplasm of bone Quantity
Item
detection of more than 3 bone metastases
boolean
C0153690 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Prior radiation therapy Secondary malignant neoplasm of bone Symptomatic
Item
previous radiation therapy of symptomatic bone metastases
boolean
C0279134 (UMLS CUI [1,1])
C0153690 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Pain management | Analgesics, Opioid
Item
pain management with opioid analgesics
boolean
C0002766 (UMLS CUI [1])
C0002772 (UMLS CUI [2])
Neoplasm Metastasis Visceral | Metastatic malignant neoplasm to brain
Item
detection of visceral metastases or brain metastases
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
Neuroendocrine Differentiation | Cell Small Differentiation | Histology Biopsy
Item
neuroendocrine and / or small cell differentiation in histology of the biopsy
boolean
C1709218 (UMLS CUI [1])
C0007634 (UMLS CUI [2,1])
C0700321 (UMLS CUI [2,2])
C0007589 (UMLS CUI [2,3])
C0344441 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Charlson Comorbidity Index
Item
charlson comorbidity index > 2
boolean
C4546361 (UMLS CUI [1])
ECOG performance status
Item
ecog performance score > 1
boolean
C1520224 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident
Item
myocardial infarction or stroke within the last 6 months
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Cardiovascular Disease Major New York Heart Association Classification | Lung disease | PO2 measurement | Kidney Disease | Liver disease | Hematological Disease | Bone marrow aplasia Severe
Item
existing major cardiovascular (grade iii - iv according to nyha), pulmonary (po2 <60 mmhg), renal, hepatic or hematopoietic (eg, severe bone marrow aplasia) disease
boolean
C0007222 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0024115 (UMLS CUI [2])
C1283004 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C1368107 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Mental Disorders, Severe | Institutionalized Persons
Item
severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution
boolean
C4046029 (UMLS CUI [1])
C0376326 (UMLS CUI [2])
Study Subject Participation Status | Interventional Study | Metastatic Prostate Carcinoma
Item
simultaneous participation in another clinical trial with interventional character of the metastatic prostate cancer
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C0936223 (UMLS CUI [3])
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