ID

19065

Description

A Study of Pertuzumab in Participants With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02480010

Link

https://clinicaltrials.gov/show/NCT02480010

Keywords

Versions (1)
  1. 12/2/16 12/2/16 -
Uploaded on

December 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00010313 NCT02480010

English

Eligibility Prostate Cancer NCT02480010

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults greater than (>) 18 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically documented adenocarcinoma of the prostate resistant to hormone therapy, progressed at 4 to 6 weeks following anti-androgen withdrawal
Description

Adenocarcinoma of prostate Hormone Therapy Resistant | Androgen Antagonists Withdrawal | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0332325
UMLS CUI [2,1]
C0002842
UMLS CUI [2,2]
C2349954
UMLS CUI [3]
C0242656
prostate-specific antigen (psa) values at least 20 ng/ml among those with asymptomatic or mildly symptomatic disease
Description

Prostate specific antigen measurement Asymptomatic Disease | Prostate specific antigen measurement Disease Symptomatic Mild

Data type

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C2936329
UMLS CUI [2,1]
C0201544
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0231220
UMLS CUI [2,4]
C2945599
karnofsky performance status (kps) at least 80 percent (%)
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
castrate testosterone less than (<) 50 ng/dl
Description

Castrated male Testosterone measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1319065
UMLS CUI [1,2]
C0523912
life expectancy at least 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
left ventricular ejection fraction (lvef) at least 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
adequate hematologic, hepatic, and renal function
Description

Hematologic function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy, radionucleotide therapy, or immunotherapy for prostate cancer
Description

Chemotherapy Prostate carcinoma | Immunotherapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0600139
systemic corticosteroids within 1 month prior to screening
Description

Adrenal Cortex Hormones Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205373
bisphosphonates within 6 months, narcotic analgesics within 2 weeks, or any investigational agent with 28 days of study drug
Description

Diphosphonates | Narcotic Analgesics | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0027409
UMLS CUI [3]
C0013230
prior cumulative doxorubicin dose of > 360 mg/m^2 or equivalent
Description

Doxorubicin Cumulative Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
central nervous system (cns) or pulmonary metastases
Description

CNS metastases | Secondary malignant neoplasm of lung

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0153676
other malignancies, except adequately treated basal or squamous cell skin cancer
Description

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
significant cardiovascular disease
Description

Cardiovascular Disease Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0750502
active/uncontrolled concurrent illness or infection
Description

Comorbidity Uncontrolled | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
major surgery or traumatic injury within 4 weeks of study drug
Description

major surgery | Traumatic injury

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3263723
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Similar models

Eligibility Prostate Cancer NCT02480010

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adults greater than (>) 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate Hormone Therapy Resistant | Androgen Antagonists Withdrawal | Disease Progression
Item
histologically documented adenocarcinoma of the prostate resistant to hormone therapy, progressed at 4 to 6 weeks following anti-androgen withdrawal
boolean
C0007112 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0332325 (UMLS CUI [1,3])
C0002842 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
Prostate specific antigen measurement Asymptomatic Disease | Prostate specific antigen measurement Disease Symptomatic Mild
Item
prostate-specific antigen (psa) values at least 20 ng/ml among those with asymptomatic or mildly symptomatic disease
boolean
C0201544 (UMLS CUI [1,1])
C2936329 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C2945599 (UMLS CUI [2,4])
Karnofsky Performance Status
Item
karnofsky performance status (kps) at least 80 percent (%)
boolean
C0206065 (UMLS CUI [1])
Castrated male Testosterone measurement
Item
castrate testosterone less than (<) 50 ng/dl
boolean
C1319065 (UMLS CUI [1,1])
C0523912 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) at least 50%
boolean
C0428772 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic, and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Prostate carcinoma | Immunotherapy Prostate carcinoma
Item
prior chemotherapy, radionucleotide therapy, or immunotherapy for prostate cancer
boolean
C0392920 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Adrenal Cortex Hormones Systemic
Item
systemic corticosteroids within 1 month prior to screening
boolean
C0001617 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Diphosphonates | Narcotic Analgesics | Investigational New Drugs
Item
bisphosphonates within 6 months, narcotic analgesics within 2 weeks, or any investigational agent with 28 days of study drug
boolean
C0012544 (UMLS CUI [1])
C0027409 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Doxorubicin Cumulative Dose
Item
prior cumulative doxorubicin dose of > 360 mg/m^2 or equivalent
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
CNS metastases | Secondary malignant neoplasm of lung
Item
central nervous system (cns) or pulmonary metastases
boolean
C0686377 (UMLS CUI [1])
C0153676 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
other malignancies, except adequately treated basal or squamous cell skin cancer
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Cardiovascular Disease Significant
Item
significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease Uncontrolled
Item
active/uncontrolled concurrent illness or infection
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
major surgery | Traumatic injury
Item
major surgery or traumatic injury within 4 weeks of study drug
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
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