ID

31596

Descrição

Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00776594

Link

https://clinicaltrials.gov/show/NCT00776594

Palavras-chave

Versões (1)
  1. 10/09/2018 10/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00776594

Inglês

Eligibility Prostate Cancer NCT00776594

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of biopsy documented prostate cancer (any gleason score)
Descrição

Prostate carcinoma Gleason score Biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3203027
UMLS CUI [1,3]
C0005558
past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy)
Descrição

Prostatectomy In the past | Salvage Radiotherapy to prostate | Salvage Radiotherapy to pelvis | Salvage Radiotherapy to prostate Absent | Salvage Radiotherapy to pelvis Absent | External beam radiotherapy | Brachytherapy | External beam radiotherapy Absent | Brachytherapy Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C0085405
UMLS CUI [2,2]
C0948317
UMLS CUI [3,1]
C0085405
UMLS CUI [3,2]
C1536155
UMLS CUI [4,1]
C0085405
UMLS CUI [4,2]
C0948317
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0085405
UMLS CUI [5,2]
C1536155
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C0419095
UMLS CUI [7]
C0006098
UMLS CUI [8,1]
C0419095
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C0006098
UMLS CUI [9,2]
C0332197
if past prostatectomy, pathologic stage no greater than t1-3, n1, m0
Descrição

Prostatectomy In the past TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C1444637
UMLS CUI [1,3]
C3258246
psa recurrence with psadt < 18 months. there is no minimum psa for prostatectomy patients. for patients treated with primary radiation therapy psa should be greater than 2.0 ng/ml
Descrição

Prostate-Specific Antigen Recurrence | Prostate-Specific Antigen Doubling Time | Prostate specific antigen measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C0034897
UMLS CUI [2,1]
C0138741
UMLS CUI [2,2]
C2986483
UMLS CUI [3]
C0201544
no evidence of recurrent disease on exam, bone scan, ct/mri abdomen/pelvis or cxr
Descrição

Recurrent disease Absent Physical Examination | Recurrent disease Absent Bone scan | Recurrent disease Absent CT of abdomen | Recurrent disease Absent MRI of abdomen | Recurrent disease Absent CT of Pelvis | Recurrent disease Absent MRI of Pelvis | Recurrent disease Absent Chest X-ray

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0203668
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0412620
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0412693
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0412628
UMLS CUI [6,1]
C0277556
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0203201
UMLS CUI [7,1]
C0277556
UMLS CUI [7,2]
C0332197
UMLS CUI [7,3]
C0039985
prior adt allowed if < 6 months and testosterone recovered to within 50 units (ng/dl) of normal range
Descrição

Antiandrogen therapy Previous | Testosterone Recovered | Testosterone measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0039601
UMLS CUI [2,2]
C0521108
UMLS CUI [3]
C0523912
ecog performance status of 0-1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count of >1,500
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100,000
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
hg > 8g/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
no history of bleeding or thromboses within the last 12 months that required medical intervention
Descrição

Absence Hemorrhage Requirement Intervention | Absence Thrombosis Requirement Intervention

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0184661
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0040053
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0184661
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
Descrição

Malignant Neoplasms | Exception Prostate carcinoma | Exception Skin carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
medical condition requiring concomitant corticosteroids
Descrição

Medical condition Requirement Adrenal Cortex Hormones

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
active infection
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
prior chemotherapy allowed if was < 6 cycles and > 6 months prior to study entry
Descrição

Prior Chemotherapy allowed | Relationship Chemotherapy cycle Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1302181
UMLS CUI [2,3]
C1265611
documented local recurrence or metastatic prostate cancer
Descrição

Prostate cancer recurrent Local | Secondary malignant neoplasm of prostate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0278838
UMLS CUI [1,2]
C0205276
UMLS CUI [2]
C0347001
inability to comply with study and/or follow-up procedures
Descrição

Protocol Compliance Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
life expectancy of less than 2 years
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a genentech-sponsored bevacizumab cancer study
Descrição

Study Subject Participation Status | Experimental drug | Exception Bevacizumab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0304229
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0796392
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Similar models

Eligibility Prostate Cancer NCT00776594

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma Gleason score Biopsy
Item
history of biopsy documented prostate cancer (any gleason score)
boolean
C0600139 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Prostatectomy In the past | Salvage Radiotherapy to prostate | Salvage Radiotherapy to pelvis | Salvage Radiotherapy to prostate Absent | Salvage Radiotherapy to pelvis Absent | External beam radiotherapy | Brachytherapy | External beam radiotherapy Absent | Brachytherapy Absent
Item
past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy)
boolean
C0033573 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0085405 (UMLS CUI [2,1])
C0948317 (UMLS CUI [2,2])
C0085405 (UMLS CUI [3,1])
C1536155 (UMLS CUI [3,2])
C0085405 (UMLS CUI [4,1])
C0948317 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0085405 (UMLS CUI [5,1])
C1536155 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0419095 (UMLS CUI [6])
C0006098 (UMLS CUI [7])
C0419095 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0006098 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
Prostatectomy In the past TNM clinical staging
Item
if past prostatectomy, pathologic stage no greater than t1-3, n1, m0
boolean
C0033573 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Prostate-Specific Antigen Recurrence | Prostate-Specific Antigen Doubling Time | Prostate specific antigen measurement
Item
psa recurrence with psadt < 18 months. there is no minimum psa for prostatectomy patients. for patients treated with primary radiation therapy psa should be greater than 2.0 ng/ml
boolean
C0138741 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0138741 (UMLS CUI [2,1])
C2986483 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])
Recurrent disease Absent Physical Examination | Recurrent disease Absent Bone scan | Recurrent disease Absent CT of abdomen | Recurrent disease Absent MRI of abdomen | Recurrent disease Absent CT of Pelvis | Recurrent disease Absent MRI of Pelvis | Recurrent disease Absent Chest X-ray
Item
no evidence of recurrent disease on exam, bone scan, ct/mri abdomen/pelvis or cxr
boolean
C0277556 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0203668 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0412620 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0412693 (UMLS CUI [4,3])
C0277556 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0412628 (UMLS CUI [5,3])
C0277556 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0203201 (UMLS CUI [6,3])
C0277556 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0039985 (UMLS CUI [7,3])
Antiandrogen therapy Previous | Testosterone Recovered | Testosterone measurement
Item
prior adt allowed if < 6 months and testosterone recovered to within 50 units (ng/dl) of normal range
boolean
C0279492 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0039601 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
C0523912 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count of >1,500
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100,000
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hg > 8g/dl
boolean
C0518015 (UMLS CUI [1])
Absence Hemorrhage Requirement Intervention | Absence Thrombosis Requirement Intervention
Item
no history of bleeding or thromboses within the last 12 months that required medical intervention
boolean
C0332197 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0040053 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0184661 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Prostate carcinoma | Exception Skin carcinoma
Item
history of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Medical condition Requirement Adrenal Cortex Hormones
Item
medical condition requiring concomitant corticosteroids
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Prior Chemotherapy allowed | Relationship Chemotherapy cycle Quantity
Item
prior chemotherapy allowed if was < 6 cycles and > 6 months prior to study entry
boolean
C1514457 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C1302181 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Prostate cancer recurrent Local | Secondary malignant neoplasm of prostate
Item
documented local recurrence or metastatic prostate cancer
boolean
C0278838 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0347001 (UMLS CUI [2])
Protocol Compliance Unable
Item
inability to comply with study and/or follow-up procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of less than 2 years
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status | Experimental drug | Exception Bevacizumab
Item
current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a genentech-sponsored bevacizumab cancer study
boolean
C2348568 (UMLS CUI [1])
C0304229 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0796392 (UMLS CUI [3,2])
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