ID

19738

Description

A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC); ODM derived from: https://clinicaltrials.gov/show/NCT00385827

Link

https://clinicaltrials.gov/show/NCT00385827

Keywords

Versions (1)
  1. 1/24/17 1/24/17 -
Uploaded on

January 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cancer, Prostate DRKS00009650 NCT00385827

English

Eligibility Cancer, Prostate NCT00385827

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically (the study of tissue under the microscope) or cytologically (the study of cells) confirmed adenocarcinoma (a malignant epithelial tumor with a glandular organization) of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
radiologically (gamma and computed topography [ct] scans) documented metastatic disease
Description

Neoplasm Metastasis X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0040405
at least 6 weeks of treatment with 1 prior docetaxel-based chemotherapy for metastatic hormone refractory prostate cancer (hrpc)
Description

Chemotherapy Docetaxel Based Hormone refractory prostate cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0246415
UMLS CUI [1,3]
C1705938
UMLS CUI [1,4]
C1328504
UMLS CUI [1,5]
C1522484
disease progression, during or within 6 months of stopping of prior docetaxel-based therapy, based on one of the following: serum prostate specific antigen (psa) progression, defined as a rise in at least 2 consecutive serum psa values, each obtained at least 1 week apart or radiologic disease progression: if disease progression is shown by bone scan only, then disease progression is defined by the appearance of 2 or more new bone lesions (abnormal area of tissue, such as a wound, sore, rash, or boil)
Description

Disease Progression | Therapeutic procedure Docetaxel Based Discontinued | Serum Prostate Specific Antigen Increased | Disease Progression Diagnostic radiologic examination | Disease Progression Radioisotope scan of bone | Bone lesion New Quantity | wound | Sore skin | Exanthema | furuncle

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0246415
UMLS CUI [2,3]
C1705938
UMLS CUI [2,4]
C1444662
UMLS CUI [3]
C1883014
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0043299
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0203668
UMLS CUI [6,1]
C0238792
UMLS CUI [6,2]
C0205314
UMLS CUI [6,3]
C1265611
UMLS CUI [7]
C0043250
UMLS CUI [8]
C1442877
UMLS CUI [9]
C0015230
UMLS CUI [10]
C0242301
orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram per decilliter (ng/dl) by means of pharmacological/chemical castration
Description

Orchiectomy | Testosterone amount caused by Medical Castration | Testosterone amount caused by Chemical male castration

Data type

boolean

Alias
UMLS CUI [1]
C0029189
UMLS CUI [2,1]
C0039601
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C1513054
UMLS CUI [3,1]
C0039601
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0015127
UMLS CUI [3,4]
C0455189
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no evidence of a brain tumor
Description

Brain Neoplasm Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0006118
UMLS CUI [1,2]
C3887511
no more than 1 line of chemotherapy for metastatic prostate cancer
Description

Chemotherapy Regimen Quantity Metastatic Prostate Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0936223
no prior mitoxantrone treatment
Description

Mitoxantrone

Data type

boolean

Alias
UMLS CUI [1]
C0026259
prior malignancy (other than prostate cancer) except adequately treated superficial bladder cancer, basal cell or squamous cell carcinoma (type of cancer) of the skin, or other cancer for which the subject has been disease-free for atleast 3 years
Description

Malignant Neoplasm | Prostate carcinoma | Superficial carcinoma of urinary bladder Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Malignant Neoplasm Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0600139
UMLS CUI [3,1]
C1336527
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0007117
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0553723
UMLS CUI [5,2]
C1522326
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
no human immunodeficiency virus (hiv) (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) seropositivity or hepatitis (inflammation of the liver) b or c infection
Description

HIV Seropositivity | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Similar models

Eligibility Cancer, Prostate NCT00385827

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically (the study of tissue under the microscope) or cytologically (the study of cells) confirmed adenocarcinoma (a malignant epithelial tumor with a glandular organization) of the prostate
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis X-Ray Computed Tomography
Item
radiologically (gamma and computed topography [ct] scans) documented metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Chemotherapy Docetaxel Based Hormone refractory prostate cancer metastatic
Item
at least 6 weeks of treatment with 1 prior docetaxel-based chemotherapy for metastatic hormone refractory prostate cancer (hrpc)
boolean
C0392920 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C1328504 (UMLS CUI [1,4])
C1522484 (UMLS CUI [1,5])
Disease Progression | Therapeutic procedure Docetaxel Based Discontinued | Serum Prostate Specific Antigen Increased | Disease Progression Diagnostic radiologic examination | Disease Progression Radioisotope scan of bone | Bone lesion New Quantity | wound | Sore skin | Exanthema | furuncle
Item
disease progression, during or within 6 months of stopping of prior docetaxel-based therapy, based on one of the following: serum prostate specific antigen (psa) progression, defined as a rise in at least 2 consecutive serum psa values, each obtained at least 1 week apart or radiologic disease progression: if disease progression is shown by bone scan only, then disease progression is defined by the appearance of 2 or more new bone lesions (abnormal area of tissue, such as a wound, sore, rash, or boil)
boolean
C0242656 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
C1444662 (UMLS CUI [2,4])
C1883014 (UMLS CUI [3])
C0242656 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5,1])
C0203668 (UMLS CUI [5,2])
C0238792 (UMLS CUI [6,1])
C0205314 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0043250 (UMLS CUI [7])
C1442877 (UMLS CUI [8])
C0015230 (UMLS CUI [9])
C0242301 (UMLS CUI [10])
Orchiectomy | Testosterone amount caused by Medical Castration | Testosterone amount caused by Chemical male castration
Item
orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram per decilliter (ng/dl) by means of pharmacological/chemical castration
boolean
C0029189 (UMLS CUI [1])
C0039601 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C1513054 (UMLS CUI [2,4])
C0039601 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0015127 (UMLS CUI [3,3])
C0455189 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Brain Neoplasm Evidence
Item
no evidence of a brain tumor
boolean
C0006118 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity Metastatic Prostate Carcinoma
Item
no more than 1 line of chemotherapy for metastatic prostate cancer
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0936223 (UMLS CUI [1,3])
Mitoxantrone
Item
no prior mitoxantrone treatment
boolean
C0026259 (UMLS CUI [1])
Malignant Neoplasm | Prostate carcinoma | Superficial carcinoma of urinary bladder Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Malignant Neoplasm Disease Free of
Item
prior malignancy (other than prostate cancer) except adequately treated superficial bladder cancer, basal cell or squamous cell carcinoma (type of cancer) of the skin, or other cancer for which the subject has been disease-free for atleast 3 years
boolean
C0006826 (UMLS CUI [1])
C0600139 (UMLS CUI [2])
C1336527 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0007117 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0553723 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
no human immunodeficiency virus (hiv) (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) seropositivity or hepatitis (inflammation of the liver) b or c infection
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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