ID

22874

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00673127

Nyckelord

Versioner (2)
  1. 2017-06-09 2017-06-09 -
  2. 2017-06-13 2017-06-13 -
Uppladdad den

13 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00673127

Engelsk

Eligibility Prostate Cancer NCT00673127

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Prostate specific antigen measurement | total serum testosterone measurement

Datatyp

boolean

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

Chemotherapy Discontinued

Datatyp

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
Beskrivning

Estrogens Discontinued

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Renal function | Liver function | Bone Marrow function

Datatyp

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
Beskrivning

Electrocardiogram QT interval normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0853831
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

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
Beskrivning

Major surgery | Therapeutic radiology procedure

Datatyp

boolean

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

Strontium-89 | Samarium 153

Datatyp

boolean

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

Thromboembolism

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

perampanel

Datatyp

boolean

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

CYP3A4 Substrate Sensitive

Datatyp

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
Beskrivning

Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
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Similar models

Eligibility Prostate Cancer NCT00673127

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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