Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age >= 18 years
boolean
adenocarcinoma of the prostate
Item
Histopathologically or cytologically proven adenocarcinoma of the prostate
boolean
metastatic prostate adenocarcinoma
Item
Documented metastatic prostate adenocarcinoma
boolean
progression while on androgen ablation therapy
Item
Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
boolean
ECOG performance status <= 2
Item
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
boolean
Adequate hematologic, renal and hepatic function
Item
Adequate hematologic, renal and hepatic function
boolean
Life expectancy
Item
Life expectancy >= 3 months
boolean
C0001779 (UMLS CUI)
Item Group
Exclusion Criteria
chemotherapy, except estramustine
Item
Prior chemotherapy, except estramustine
boolean
chemotherapy with docetaxel
Item
Prior chemotherapy with docetaxel
boolean
isotope therapy
Item
Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
boolean
contraindications to the use of corticosteroids
Item
One or more contraindications to the use of corticosteroids
boolean
cancer-related hypercalcemia
Item
History of cancer-related hypercalcemia
boolean
Item Group
Medical Concepts
Age
Item
Age
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Prostate Adenocarcinoma
Item
Prostate Adenocarcinoma
string
C0007112 (UMLS CUI)
399490008 (SNOMED CT 2010_0731)
10060862 (MedDRA 13.1)
Metastatic prostate cancer
Item
Metastatic prostate cancer
string
C0936223 (UMLS CUI)
10036909 (MedDRA 13.1)
Disease Progression
Item
Course of illness
string
C0242656 (UMLS CUI)
246453008 (SNOMED CT 2010_0731)
10061818 (MedDRA 13.1)
androgen ablation therapy
Item
androgen ablation therapy
string
CL382748 (UMLS CUI)
PSA
Item
Prostate-Specific Antigen
string
C0138741 (UMLS CUI)
102687007 (SNOMED CT 2010_0731)
MTHU001466 (LOINC Version 232)
Imaging
Item
Diagnostic Imaging
string
C0011923 (UMLS CUI)
363679005 (SNOMED CT 2010_0731)
ECOG performance status - grade 0
Item
ECOG performance status - grade 0
string
C1828078 (UMLS CUI)
425389002 (SNOMED CT 2010_0731)
ECOG performance status - grade 1
Item
ECOG performance status - grade 1
string
C1827388 (UMLS CUI)
422512005 (SNOMED CT 2010_0731)
ECOG performance status - grade 2
Item
ECOG performance status - grade 2
string
C1828242 (UMLS CUI)
422894000 (SNOMED CT 2010_0731)
Hematologic function
Item
Hematologic function
string
C0221130 (UMLS CUI)
86084001 (SNOMED CT 2010_0731)
Renal function
Item
kidney function
string
C0232805 (UMLS CUI)
11953005 (SNOMED CT 2010_0731)
Liver function
Item
Hepatic function
string
C0232741 (UMLS CUI)
79036002 (SNOMED CT 2010_0731)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Estramustine
Item
Estramustine (substance)
string
C0014921 (UMLS CUI)
386909008 (SNOMED CT 2010_0731)
Docetaxel
Item
Taxotere
string
C0699967 (UMLS CUI)
386918005 (SNOMED CT 2010_0731)
radioisotope therapy
Item
radioisotope therapy
string
C0543487 (UMLS CUI)
Sr89 therapy
Item
Strontium 89 therapy
string
C0454108 (UMLS CUI)
228701001 (SNOMED CT 2010_0731)
Sm-153
Item
Samarium 153
string
C0677942 (UMLS CUI)
419804008 (SNOMED CT 2010_0731)
Contraindication to medical treatment
Item
Contraindication to medical treatment
string
C1301624 (UMLS CUI)
10010833 (MedDRA 13.1)
Corticosteroids
Item
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
hypercalcaemia
Item
Hypercalcemia
string
C0020437 (UMLS CUI)
66931009 (SNOMED CT 2010_0731)
10020583 (MedDRA 13.1)
E83.52 (ICD-10-CM Version 2010)
275.42 (ICD-9-CM Version 2011)
E12270 (CTCAE Version 4.03)

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