ID

36853

Descrição

Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02064582

Link

https://clinicaltrials.gov/show/NCT02064582

Palavras-chave

Versões (1)
  1. 16/06/2019 16/06/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de junho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02064582

Inglês

Eligibility Prostate Cancer NCT02064582

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven adenocarcinoma of the prostate within 6 months of screening
Descrição

Adenocarcinoma of prostate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007112
eastern cooperative oncology group(ecog) score 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ and and blood marrow function
Descrição

Organ function | Hematologic function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0221130
must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
Descrição

Antiandrogen therapy Long-term | External Beam Radiation Therapy | Combined Modality Therapy High risk Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0443252
UMLS CUI [2]
C1517033
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C4319571
UMLS CUI [3,3]
C0600139
patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
Descrição

Biopsy of prostate Targeted

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C1521840
men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception
Descrição

Gender Partner in relationship Childbearing Potential | Gender Sexually active Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with agents known to have endocrine effects on prostate cancer
Descrição

Pharmacotherapy Endocrine effects Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0678896
UMLS CUI [1,3]
C0600139
treatment with corticosteroids within 4 weeks of enrollment
Descrição

Adrenal Cortex Hormones

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001617
treatment with androgens within 6 months of enrollment
Descrição

Androgen therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279493
may not be receiving any other investigational agents
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
prostate specific antigen greater than 160ng/dl
Descrição

Prostate specific antigen measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201544
history of malignancy( other than non-melanoma skin cancer) within 5 years
Descrição

Malignant Neoplasms | Exception Skin carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
uncontrolled intercurrent illness
Descrição

Comorbidity Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
cardiovascular event within 6 months of enrollment
Descrição

Cardiovascular event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1320716
seizure or seizure disorder history
Descrição

Seizure | Epilepsy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0014544
contraindications to mri- pacemakers, clips, etc
Descrição

Medical contraindication MRI | Artificial cardiac pacemaker | Clips

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0175722
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Similar models

Eligibility Prostate Cancer NCT02064582

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically proven adenocarcinoma of the prostate within 6 months of screening
boolean
C0007112 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group(ecog) score 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function | Hematologic function
Item
adequate organ and and blood marrow function
boolean
C0678852 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
Antiandrogen therapy Long-term | External Beam Radiation Therapy | Combined Modality Therapy High risk Prostate carcinoma
Item
must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
boolean
C0279492 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C1517033 (UMLS CUI [2])
C0009429 (UMLS CUI [3,1])
C4319571 (UMLS CUI [3,2])
C0600139 (UMLS CUI [3,3])
Biopsy of prostate Targeted
Item
patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
boolean
C0194804 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
Gender Partner in relationship Childbearing Potential | Gender Sexually active Contraceptive methods
Item
men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pharmacotherapy Endocrine effects Prostate carcinoma
Item
prior treatment with agents known to have endocrine effects on prostate cancer
boolean
C0013216 (UMLS CUI [1,1])
C0678896 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Adrenal Cortex Hormones
Item
treatment with corticosteroids within 4 weeks of enrollment
boolean
C0001617 (UMLS CUI [1])
Androgen therapy
Item
treatment with androgens within 6 months of enrollment
boolean
C0279493 (UMLS CUI [1])
Investigational New Drugs
Item
may not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Prostate specific antigen measurement
Item
prostate specific antigen greater than 160ng/dl
boolean
C0201544 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma
Item
history of malignancy( other than non-melanoma skin cancer) within 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cardiovascular event
Item
cardiovascular event within 6 months of enrollment
boolean
C1320716 (UMLS CUI [1])
Seizure | Epilepsy
Item
seizure or seizure disorder history
boolean
C0036572 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Medical contraindication MRI | Artificial cardiac pacemaker | Clips
Item
contraindications to mri- pacemakers, clips, etc
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0175722 (UMLS CUI [3])
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