ID

22874

Description

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00673127

Link

https://clinicaltrials.gov/show/NCT00673127

Keywords

Versions (2)
  1. 6/9/17 6/9/17 -
  2. 6/13/17 6/13/17 -
Uploaded on

June 13, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostate Cancer NCT00673127

English

Eligibility Prostate Cancer NCT00673127

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). in the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum psa and metastatic lesions on bone scan.
Description

Prostate carcinoma Needle biopsy | Prostatectomy | Raised prostate specific antigen | Metastatic Lesion Bone scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0005560
UMLS CUI [2]
C0033573
UMLS CUI [3]
C0178415
UMLS CUI [4,1]
C1513183
UMLS CUI [4,2]
C0203668
progressive hrpc defined as a psa increase over baseline of >25% or 5ng/ml or new lesions on bone/ct scan after conventional androgen deprivation and antiandrogen withdrawal. evidence of metastatic disease based on positive ct or bone scan is not required.
Description

Hormone refractory prostate cancer Progressive | Raised prostate specific antigen | Lesion New Bone scan | Lesion New CT scan | Antiandrogen therapy conventional | Androgen Antagonists Withdrawal | Neoplasm Metastasis CT scan Positive | Neoplasm Metastasis Bone scan

Data type

boolean

Alias
UMLS CUI [1,1]
C1328504
UMLS CUI [1,2]
C0205329
UMLS CUI [2]
C0178415
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0205314
UMLS CUI [3,3]
C0203668
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0205314
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C0279492
UMLS CUI [5,2]
C0439858
UMLS CUI [6,1]
C0002842
UMLS CUI [6,2]
C2349954
UMLS CUI [7,1]
C0027627
UMLS CUI [7,2]
C0040405
UMLS CUI [7,3]
C1514241
UMLS CUI [8,1]
C0027627
UMLS CUI [8,2]
C0203668
psa of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
Description

Prostate specific antigen measurement | total serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C2210797
prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy
Description

Chemotherapy Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
prior therapy with estrogens is permitted but must have been discontinued > 4 weeks prior to registration
Description

Estrogens Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0014939
UMLS CUI [1,2]
C1444662
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal function, hepatic function, and bone marrow function as outlined in protocol
Description

Renal function | Liver function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
ecg showing a normal qt interval
Description

Electrocardiogram QT interval normal

Data type

boolean

Alias
UMLS CUI [1]
C0853831
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior therapy with ketoconazole or corticosteroids for hrpc
Description

Ketoconazole | Adrenal Cortex Hormones | Therapeutic procedure Hormone refractory prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1328504
major surgery or radiation therapy within 4 weeks
Description

Major surgery | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
strontium-89 or samarium-153 therapy within 4 weeks
Description

Strontium-89 | Samarium 153

Data type

boolean

Alias
UMLS CUI [1]
C0281385
UMLS CUI [2]
C0677942
thromboembolism in past 6 months
Description

Thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C0040038
patients who are taking drugs that may further prolong qt intervals and present a known risk for torsades de pointes.
Description

Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations At risk Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0040479
concomitant use of drugs known to be narrow therapeutic index ctp3a4
Description

perampanel

Data type

boolean

Alias
UMLS CUI [1]
C2698764
drugs that are sensitive cyp3a4 substrates
Description

CYP3A4 Substrate Sensitive

Data type

boolean

Alias
UMLS CUI [1,1]
C1142644
UMLS CUI [1,2]
C3891814
UMLS CUI [1,3]
C0332324
alcohol or drug dependence currently or in the last 6 months
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
Back to the top of the page

Similar models

Eligibility Prostate Cancer NCT00673127

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma Needle biopsy | Prostatectomy | Raised prostate specific antigen | Metastatic Lesion Bone scan
Item
histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). in the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum psa and metastatic lesions on bone scan.
boolean
C0600139 (UMLS CUI [1,1])
C0005560 (UMLS CUI [1,2])
C0033573 (UMLS CUI [2])
C0178415 (UMLS CUI [3])
C1513183 (UMLS CUI [4,1])
C0203668 (UMLS CUI [4,2])
Hormone refractory prostate cancer Progressive | Raised prostate specific antigen | Lesion New Bone scan | Lesion New CT scan | Antiandrogen therapy conventional | Androgen Antagonists Withdrawal | Neoplasm Metastasis CT scan Positive | Neoplasm Metastasis Bone scan
Item
progressive hrpc defined as a psa increase over baseline of >25% or 5ng/ml or new lesions on bone/ct scan after conventional androgen deprivation and antiandrogen withdrawal. evidence of metastatic disease based on positive ct or bone scan is not required.
boolean
C1328504 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0203668 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C0205314 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C0279492 (UMLS CUI [5,1])
C0439858 (UMLS CUI [5,2])
C0002842 (UMLS CUI [6,1])
C2349954 (UMLS CUI [6,2])
C0027627 (UMLS CUI [7,1])
C0040405 (UMLS CUI [7,2])
C1514241 (UMLS CUI [7,3])
C0027627 (UMLS CUI [8,1])
C0203668 (UMLS CUI [8,2])
Prostate specific antigen measurement | total serum testosterone measurement
Item
psa of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
boolean
C0201544 (UMLS CUI [1])
C2210797 (UMLS CUI [2])
Chemotherapy Discontinued
Item
prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Estrogens Discontinued
Item
prior therapy with estrogens is permitted but must have been discontinued > 4 weeks prior to registration
boolean
C0014939 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Bone Marrow function
Item
adequate renal function, hepatic function, and bone marrow function as outlined in protocol
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Electrocardiogram QT interval normal
Item
ecg showing a normal qt interval
boolean
C0853831 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Ketoconazole | Adrenal Cortex Hormones | Therapeutic procedure Hormone refractory prostate cancer
Item
prior therapy with ketoconazole or corticosteroids for hrpc
boolean
C0022625 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1328504 (UMLS CUI [3,2])
Major surgery | Therapeutic radiology procedure
Item
major surgery or radiation therapy within 4 weeks
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Strontium-89 | Samarium 153
Item
strontium-89 or samarium-153 therapy within 4 weeks
boolean
C0281385 (UMLS CUI [1])
C0677942 (UMLS CUI [2])
Thromboembolism
Item
thromboembolism in past 6 months
boolean
C0040038 (UMLS CUI [1])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations At risk Torsades de Pointes
Item
patients who are taking drugs that may further prolong qt intervals and present a known risk for torsades de pointes.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
perampanel
Item
concomitant use of drugs known to be narrow therapeutic index ctp3a4
boolean
C2698764 (UMLS CUI [1])
CYP3A4 Substrate Sensitive
Item
drugs that are sensitive cyp3a4 substrates
boolean
C1142644 (UMLS CUI [1,1])
C3891814 (UMLS CUI [1,2])
C0332324 (UMLS CUI [1,3])
Substance Dependence
Item
alcohol or drug dependence currently or in the last 6 months
boolean
C0038580 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial