ID

25107

Description

An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00485303

Link

https://clinicaltrials.gov/show/NCT00485303

Keywords

Versions (1)
  1. 8/26/17 8/26/17 -
Uploaded on

August 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00485303

English

Eligibility Prostatic Neoplasms NCT00485303

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology
Description

Adenocarcinoma of prostate | Neuroendocrine Differentiation Absent | Histology Non-small cell

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C1709218
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0344441
UMLS CUI [3,2]
C0445128
prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel
Description

Prior Chemotherapy Prostate carcinoma | Docetaxel

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0246415
documented prostate specific antigen (psa) progression according to prostate specific antigen working group (psawg) eligibility criteria with a psa more than (>) 5 nanogram per milliliter (ng/ml) or objective progression by response evaluation criteria in solid tumors (resist) criteria
Description

PSA Progression | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C4054264
UMLS CUI [2]
C0201544
ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per deciliter (ng/dl)
Description

Antiandrogen therapy | Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C0428413
eastern cooperative oncology group (ecog) performance status of less than equal to (<=) 2 (karnofsky performance status >= 50 percent)
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy
Description

Autoimmune Disease | Autoimmune Disease Uncontrolled | Steroid therapy Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0686904
serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Description

Comorbidity Serious | Comorbidity Uncontrolled | Communicable Disease | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0009450
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
uncontrolled hypertension (high blood pressure)
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
hemoglobin <=9.0 gram per deciliter (g/dl) without growth factor or transfusion support
Description

Hemoglobin measurement | Growth Factor Absent | Support transfusion therapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C0018284
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0436311
UMLS CUI [3,2]
C0332197
abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function
Description

Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
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Similar models

Eligibility Prostatic Neoplasms NCT00485303

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Neuroendocrine Differentiation Absent | Histology Non-small cell
Item
histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology
boolean
C0007112 (UMLS CUI [1])
C1709218 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0344441 (UMLS CUI [3,1])
C0445128 (UMLS CUI [3,2])
Prior Chemotherapy Prostate carcinoma | Docetaxel
Item
prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel
boolean
C1514457 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0246415 (UMLS CUI [2])
PSA Progression | Prostate specific antigen measurement
Item
documented prostate specific antigen (psa) progression according to prostate specific antigen working group (psawg) eligibility criteria with a psa more than (>) 5 nanogram per milliliter (ng/ml) or objective progression by response evaluation criteria in solid tumors (resist) criteria
boolean
C4054264 (UMLS CUI [1])
C0201544 (UMLS CUI [2])
Antiandrogen therapy | Serum testosterone measurement
Item
ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per deciliter (ng/dl)
boolean
C0279492 (UMLS CUI [1])
C0428413 (UMLS CUI [2])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) performance status of less than equal to (<=) 2 (karnofsky performance status >= 50 percent)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease | Autoimmune Disease Uncontrolled | Steroid therapy Patient need for
Item
active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy
boolean
C0004364 (UMLS CUI [1])
C0004364 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Comorbidity Serious | Comorbidity Uncontrolled | Communicable Disease | Communicable Disease Uncontrolled
Item
serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Uncontrolled hypertension
Item
uncontrolled hypertension (high blood pressure)
boolean
C1868885 (UMLS CUI [1])
Hemoglobin measurement | Growth Factor Absent | Support transfusion therapy Absent
Item
hemoglobin <=9.0 gram per deciliter (g/dl) without growth factor or transfusion support
boolean
C0518015 (UMLS CUI [1])
C0018284 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0436311 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Liver Dysfunction
Item
abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function
boolean
C0086565 (UMLS CUI [1])
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