ID

36968

Descrição

Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT02043678

Link

https://clinicaltrials.gov/show/NCT02043678

Palavras-chave

Versões (1)
  1. 24/06/2019 24/06/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de junho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02043678

Inglês

Eligibility Prostatic Neoplasms NCT02043678

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate
Descrição

Adenocarcinoma of prostate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007112
male subjects of age ≥ 18 years
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
prostate cancer progression documented by prostate specific antigen according to the prostate cancer working group 2 (pcwg2) criteria or radiological progression according to response evaluation criteria in solid tumors (recist), version 1.1.
Descrição

Progression of prostate cancer Prostate specific antigen measurement | Progression of prostate cancer Radiology

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1739135
UMLS CUI [1,2]
C0201544
UMLS CUI [2,1]
C1739135
UMLS CUI [2,2]
C0043299
two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis.
Descrição

Secondary malignant neoplasm of bone Quantity Bone scan | Secondary malignant neoplasm of lung Absent | Secondary malignant neoplasm of liver Absent | Neoplasm Metastasis Visceral Absent | Metastatic malignant neoplasm to brain Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0203668
UMLS CUI [2,1]
C0153676
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0442045
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0220650
UMLS CUI [5,2]
C0332197
asymptomatic or mildly symptomatic prostate cancer.
Descrição

Prostate carcinoma Asymptomatic | Prostate carcinoma Mild Symptomatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0231221
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C2945599
UMLS CUI [2,3]
C0231220
subjects who received combined androgen blockade with an anti-androgen must have shown psa(prostate specific antigen) progression after discontinuing the anti-androgen prior to enrollment.
Descrição

Combined androgen blockade | Androgen Antagonists | Raised prostate specific antigen | Status post Androgen Antagonists Discontinued

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3495882
UMLS CUI [2]
C0002842
UMLS CUI [3]
C0178415
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0002842
UMLS CUI [4,3]
C1444662
medical or surgical castration with testosterone less than 50 ng/dl (1.7nmol/l).
Descrição

Medical Castration | Male Castration | Testosterone measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513054
UMLS CUI [2]
C0007347
UMLS CUI [3]
C0523912
eastern cooperative oncology group (ecog) performance status 0 or 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior cytotoxic chemotherapy for the treatment of crpc, including taxanes, mitoxantrone and estramustine
Descrição

Cytotoxic Chemotherapy Hormone refractory prostate cancer | Taxanes | Mitoxantrone | Estramustine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1328504
UMLS CUI [2]
C0796419
UMLS CUI [3]
C0026259
UMLS CUI [4]
C0014921
any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
Descrição

Chronic disease Requirement Adrenal Cortex Hormones Dose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
UMLS CUI [1,4]
C0178602
pathological finding consistent with small cell carcinoma of the prostate
Descrição

Pathology Consistent with Small cell carcinoma of prostate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C1300585
history of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
Descrição

Neoplasm Metastasis Visceral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
history of or known brain metastasis.
Descrição

Metastatic malignant neoplasm to brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
Descrição

Lymphadenopathy Malignant | Diameter Short axis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0205282
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0522488
blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization
Descrição

Blood Transfusion | Pharmaceutical Preparations Stimulation Erythropoietin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005841
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1292856
UMLS CUI [2,3]
C0014822
imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (mri). subjects with history of spinal cord compression should have completely recovered
Descrição

Signs and Symptoms Compression of spinal cord Impending | Compression of spinal cord Impending MRI

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0037926
UMLS CUI [1,3]
C0332190
UMLS CUI [2,1]
C0037926
UMLS CUI [2,2]
C0332190
UMLS CUI [2,3]
C0024485
use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization.
Descrição

Opiate Analgesics Cancer Pain | Codeine | Propoxyphene

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0376196
UMLS CUI [1,2]
C0002771
UMLS CUI [1,3]
C0596240
UMLS CUI [2]
C0009214
UMLS CUI [3]
C0033493
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Similar models

Eligibility Prostatic Neoplasms NCT02043678

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically or cytologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Gender | Age
Item
male subjects of age ≥ 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Progression of prostate cancer Prostate specific antigen measurement | Progression of prostate cancer Radiology
Item
prostate cancer progression documented by prostate specific antigen according to the prostate cancer working group 2 (pcwg2) criteria or radiological progression according to response evaluation criteria in solid tumors (recist), version 1.1.
boolean
C1739135 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1739135 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
Secondary malignant neoplasm of bone Quantity Bone scan | Secondary malignant neoplasm of lung Absent | Secondary malignant neoplasm of liver Absent | Neoplasm Metastasis Visceral Absent | Metastatic malignant neoplasm to brain Absent
Item
two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis.
boolean
C0153690 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0153676 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0442045 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0220650 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Prostate carcinoma Asymptomatic | Prostate carcinoma Mild Symptomatic
Item
asymptomatic or mildly symptomatic prostate cancer.
boolean
C0600139 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
Combined androgen blockade | Androgen Antagonists | Raised prostate specific antigen | Status post Androgen Antagonists Discontinued
Item
subjects who received combined androgen blockade with an anti-androgen must have shown psa(prostate specific antigen) progression after discontinuing the anti-androgen prior to enrollment.
boolean
C3495882 (UMLS CUI [1])
C0002842 (UMLS CUI [2])
C0178415 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0002842 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
Medical Castration | Male Castration | Testosterone measurement
Item
medical or surgical castration with testosterone less than 50 ng/dl (1.7nmol/l).
boolean
C1513054 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0523912 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy Hormone refractory prostate cancer | Taxanes | Mitoxantrone | Estramustine
Item
prior cytotoxic chemotherapy for the treatment of crpc, including taxanes, mitoxantrone and estramustine
boolean
C0677881 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
C0796419 (UMLS CUI [2])
C0026259 (UMLS CUI [3])
C0014921 (UMLS CUI [4])
Chronic disease Requirement Adrenal Cortex Hormones Dose
Item
any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
Pathology Consistent with Small cell carcinoma of prostate
Item
pathological finding consistent with small cell carcinoma of the prostate
boolean
C0677042 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C1300585 (UMLS CUI [1,3])
Neoplasm Metastasis Visceral
Item
history of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
history of or known brain metastasis.
boolean
C0220650 (UMLS CUI [1])
Lymphadenopathy Malignant | Diameter Short axis
Item
malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
boolean
C0497156 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2,1])
C0522488 (UMLS CUI [2,2])
Blood Transfusion | Pharmaceutical Preparations Stimulation Erythropoietin
Item
blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization
boolean
C0005841 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1292856 (UMLS CUI [2,2])
C0014822 (UMLS CUI [2,3])
Signs and Symptoms Compression of spinal cord Impending | Compression of spinal cord Impending MRI
Item
imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (mri). subjects with history of spinal cord compression should have completely recovered
boolean
C0037088 (UMLS CUI [1,1])
C0037926 (UMLS CUI [1,2])
C0332190 (UMLS CUI [1,3])
C0037926 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Opiate Analgesics Cancer Pain | Codeine | Propoxyphene
Item
use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization.
boolean
C0376196 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
C0596240 (UMLS CUI [1,3])
C0009214 (UMLS CUI [2])
C0033493 (UMLS CUI [3])
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