ID

31555

Beschreibung

Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00559481

Link

https://clinicaltrials.gov/show/NCT00559481

Stichworte

Versionen (1)
  1. 03.09.18 03.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. September 2018

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00559481

Englisch

Eligibility Prostate Cancer NCT00559481

1 Formulare  
Criteria
Beschreibung

Criteria

confirmed diagnosis of prostate cancer
Beschreibung

Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
must have failed standard androgen-deprivation therapy
Beschreibung

Antiandrogen therapy failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0231175
evidence of rising psa
Beschreibung

Raised prostate specific antigen

Datentyp

boolean

Alias
UMLS CUI [1]
C0178415
patient characteristics:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
creatinine ≤ 2.0 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
ast and alt < 4 times upper limit of normal
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
bilirubin < 2.0 mg/dl
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
no active congestive heart failure
Beschreibung

Exclusion | Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0018802
no allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole
Beschreibung

Exclusion Criteria | Ketoconazole allergy | Dexamethasone allergy | Hydrocortisone allergy | Hypersensitivity Dexamethasone Component | Hypersensitivity Hydrocortisone Component | Hypersensitivity Ketoconazole Component

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0571275
UMLS CUI [3]
C0571611
UMLS CUI [4]
C0571588
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0011777
UMLS CUI [5,3]
C1705248
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0020268
UMLS CUI [6,3]
C1705248
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0022625
UMLS CUI [7,3]
C1705248
no active infection
Beschreibung

Exclusion | Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0009450
no uncontrolled glaucoma
Beschreibung

Exclusion | Glaucoma Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0017601
UMLS CUI [2,2]
C0205318
no active peptic ulcer disease
Beschreibung

Exclusion | Peptic Ulcer

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0030920
no uncontrolled diabetes mellitus
Beschreibung

Exclusion | Diabetic - poor control

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0421258
fertile patients must use effective contraception during and for 3 months after completion of study therapy
Beschreibung

Fertility Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
prior concurrent therapy:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
more than 2 weeks since prior and no concurrent drugs known to interact with study treatment
Beschreibung

Exclusion | Pharmaceutical Preparations Interaction Investigational Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0687133
UMLS CUI [2,3]
C0949266
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00559481

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Prostate carcinoma
Item
confirmed diagnosis of prostate cancer
boolean
C0600139 (UMLS CUI [1])
Antiandrogen therapy failed
Item
must have failed standard androgen-deprivation therapy
boolean
C0279492 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Raised prostate specific antigen
Item
evidence of rising psa
boolean
C0178415 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt < 4 times upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin < 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Exclusion | Congestive heart failure
Item
no active congestive heart failure
boolean
C2828389 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Exclusion Criteria | Ketoconazole allergy | Dexamethasone allergy | Hydrocortisone allergy | Hypersensitivity Dexamethasone Component | Hypersensitivity Hydrocortisone Component | Hypersensitivity Ketoconazole Component
Item
no allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole
boolean
C0680251 (UMLS CUI [1])
C0571275 (UMLS CUI [2])
C0571611 (UMLS CUI [3])
C0571588 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0011777 (UMLS CUI [5,2])
C1705248 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0020268 (UMLS CUI [6,2])
C1705248 (UMLS CUI [6,3])
C0020517 (UMLS CUI [7,1])
C0022625 (UMLS CUI [7,2])
C1705248 (UMLS CUI [7,3])
Exclusion | Communicable Disease
Item
no active infection
boolean
C2828389 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Exclusion | Glaucoma Uncontrolled
Item
no uncontrolled glaucoma
boolean
C2828389 (UMLS CUI [1])
C0017601 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Exclusion | Peptic Ulcer
Item
no active peptic ulcer disease
boolean
C2828389 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
Exclusion | Diabetic - poor control
Item
no uncontrolled diabetes mellitus
boolean
C2828389 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for 3 months after completion of study therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion | Pharmaceutical Preparations Interaction Investigational Therapy
Item
more than 2 weeks since prior and no concurrent drugs known to interact with study treatment
boolean
C2828389 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
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