ID

31596

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00776594

Nyckelord

Versioner (1)
  1. 2018-09-10 2018-09-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00776594

Engelsk

Eligibility Prostate Cancer NCT00776594

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Prostate carcinoma Gleason score Biopsy

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Prostatectomy In the past TNM clinical staging

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Antiandrogen therapy Previous | Testosterone Recovered | Testosterone measurement

Datatyp

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
Beskrivning

ECOG performance status

Datatyp

boolean

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

Absolute neutrophil count

Datatyp

boolean

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

Platelet Count measurement

Datatyp

boolean

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

Hemoglobin measurement

Datatyp

boolean

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

Absence Hemorrhage Requirement Intervention | Absence Thrombosis Requirement Intervention

Datatyp

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
Beskrivning

Exclusion Criteria

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

Malignant Neoplasms | Exception Prostate carcinoma | Exception Skin carcinoma

Datatyp

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
Beskrivning

Medical condition Requirement Adrenal Cortex Hormones

Datatyp

boolean

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

Communicable Disease

Datatyp

boolean

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

Prior Chemotherapy allowed | Relationship Chemotherapy cycle Quantity

Datatyp

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
Beskrivning

Prostate cancer recurrent Local | Secondary malignant neoplasm of prostate

Datatyp

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
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

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

Life Expectancy

Datatyp

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
Beskrivning

Study Subject Participation Status | Experimental drug | Exception Bevacizumab

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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