ID

21038

Beschrijving

Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00286091

Link

https://clinicaltrials.gov/show/NCT00286091

Trefwoorden

Versies (1)
  1. 04-04-17 04-04-17 -
Geüploaded op

4 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hormone Refractory Prostate Cancer DRKS00009649 NCT00286091

Engels

Eligibility Hormone Refractory Prostate Cancer NCT00286091

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men with histologically confirmed prostate cancer
Beschrijving

Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
bilateral orchiectomy at least 6 months before randomization or continuous androgen-deprivation therapy (adt) with a gonadotropin releasing hormone (gnrh) agonist or antagonist for at least 6 months before randomization
Beschrijving

Male Castration | Antiandrogen therapy | Gonadotropin Releasing Hormone Receptor Agonist | Gonadotropin releasing hormone antagonist

Datatype

boolean

Alias
UMLS CUI [1]
C0007347
UMLS CUI [2]
C0279492
UMLS CUI [3]
C2267073
UMLS CUI [4]
C1268855
total testosterone level less than 50 ng/dl,
Beschrijving

total serum testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C2210797
hormone refractory (androgen independent) prostate cancer demonstrated during continuous adt/post-orchiectomy defined as: 3 consecutive prostate-specific antigen (psa) values with psa1 < psa2 < psa3, each psa value must be separated by at least 2 weeks, psa2 and psa3 greater than or equal to 1.0 ng/ml,
Beschrijving

Hormone refractory prostate cancer | androgen independent prostate cancer | Antiandrogen therapy | Orchiectomy Status post | Prostate specific antigen measurement Consecutive Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2]
C1654637
UMLS CUI [3]
C0279492
UMLS CUI [4,1]
C0029189
UMLS CUI [4,2]
C0231290
UMLS CUI [5,1]
C0201544
UMLS CUI [5,2]
C1707491
UMLS CUI [5,3]
C1265611
high risk for development of bone metastasis defined as psa value greater than or equal to 8.0 ng/ml, obtained no more than 3 months before randomization or psa doubling time less than or equal to 10.0 months
Beschrijving

Secondary malignant neoplasm of bone Development High risk | Prostate specific antigen measurement | Prostate-Specific Antigen Doubling Time

Datatype

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0243107
UMLS CUI [1,3]
C0332167
UMLS CUI [2]
C0201544
UMLS CUI [3,1]
C0138741
UMLS CUI [3,2]
C2986483
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior or current evidence of radiographically detectable bone metastasis
Beschrijving

Secondary malignant neoplasm of bone Detectable Radiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C3830527
UMLS CUI [1,3]
C0034571
known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable)
Beschrijving

Involvement metastatic Organ distant | Secondary malignant neoplasm of lymph node Region Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0443203
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0005898
UMLS CUI [2,3]
C1552551
prior or current intravenous bisphosphonate administration
Beschrijving

Intravenous bisphosphonates Administration

Datatype

boolean

Alias
UMLS CUI [1,1]
C1955566
UMLS CUI [1,2]
C1533734
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Similar models

Eligibility Hormone Refractory Prostate Cancer NCT00286091

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
men with histologically confirmed prostate cancer
boolean
C0600139 (UMLS CUI [1])
Male Castration | Antiandrogen therapy | Gonadotropin Releasing Hormone Receptor Agonist | Gonadotropin releasing hormone antagonist
Item
bilateral orchiectomy at least 6 months before randomization or continuous androgen-deprivation therapy (adt) with a gonadotropin releasing hormone (gnrh) agonist or antagonist for at least 6 months before randomization
boolean
C0007347 (UMLS CUI [1])
C0279492 (UMLS CUI [2])
C2267073 (UMLS CUI [3])
C1268855 (UMLS CUI [4])
total serum testosterone measurement
Item
total testosterone level less than 50 ng/dl,
boolean
C2210797 (UMLS CUI [1])
Hormone refractory prostate cancer | androgen independent prostate cancer | Antiandrogen therapy | Orchiectomy Status post | Prostate specific antigen measurement Consecutive Quantity
Item
hormone refractory (androgen independent) prostate cancer demonstrated during continuous adt/post-orchiectomy defined as: 3 consecutive prostate-specific antigen (psa) values with psa1 < psa2 < psa3, each psa value must be separated by at least 2 weeks, psa2 and psa3 greater than or equal to 1.0 ng/ml,
boolean
C1328504 (UMLS CUI [1])
C1654637 (UMLS CUI [2])
C0279492 (UMLS CUI [3])
C0029189 (UMLS CUI [4,1])
C0231290 (UMLS CUI [4,2])
C0201544 (UMLS CUI [5,1])
C1707491 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Secondary malignant neoplasm of bone Development High risk | Prostate specific antigen measurement | Prostate-Specific Antigen Doubling Time
Item
high risk for development of bone metastasis defined as psa value greater than or equal to 8.0 ng/ml, obtained no more than 3 months before randomization or psa doubling time less than or equal to 10.0 months
boolean
C0153690 (UMLS CUI [1,1])
C0243107 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
C0201544 (UMLS CUI [2])
C0138741 (UMLS CUI [3,1])
C2986483 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of bone Detectable Radiography
Item
prior or current evidence of radiographically detectable bone metastasis
boolean
C0153690 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
Involvement metastatic Organ distant | Secondary malignant neoplasm of lymph node Region Any
Item
known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable)
boolean
C1314939 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0443203 (UMLS CUI [1,4])
C0686619 (UMLS CUI [2,1])
C0005898 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Intravenous bisphosphonates Administration
Item
prior or current intravenous bisphosphonate administration
boolean
C1955566 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
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