ID

6352

Description

NCIC-PR.11 Eligibility Worksheet Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6B77A6FA-9AF8-CC7A-E040-BB89AD434302

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6B77A6FA-9AF8-CC7A-E040-BB89AD434302

Keywords

Versions (2)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

December 18, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer NCT00499174 Registration - NCIC-PR.11 Eligibility Worksheet Form - 2897735v1.0

English

National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)

1 forms  
  1. StudyEvent: NCIC-PR.11 Eligibility Worksheet Form
    1. National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
Eligibility Criteria
Description

Eligibility Criteria

Patient has histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization
Description

HistologicallyConfirmationProstateAdenocarcinomaDiagnosisPriorRandomizationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25458
UMLS 2011AA ObjectClass
C0750484
NCI Thesaurus ObjectClass
C15220
UMLS 2011AA ObjectClass
C0011900
NCI Thesaurus ObjectClass
C25527
UMLS 2011AA ObjectClass
C0205462
NCI Thesaurus ObjectClass
C2919
UMLS 2011AA ObjectClass
C0007112
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of diagnosis (MM DD YYYY)
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Clinical T Stage
Description

ProstateTumorClinicalTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property
C25728
UMLS 2011AA Property
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Gleason Grade, Score (sum)
Description

GleasonScoreCombinedPatternValue

Data type

double

Alias
NCI Thesaurus Property
C25454
UMLS 2011AA Property
C0205195
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25336
UMLS 2011AA Property
C0449774
PSA <=10.0 ng/ml (ug/L Note: for patients who have received prior treatment with 5-alpha reductase inhibitors 5ARI must adhere to the following criteria: Duration of 5ARI exposure prior to date of baseline PSA Eligible PSA value ng/ml or ug/L < 2 months <= 10.0 2 months-6 months <= 7.0 > 6 months <= 5.0)
Description

LaboratoryProcedureProstate-SpecificAntigenEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
PSA Value (total) (ng/ml ug/L)
Description

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue

Data type

double

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17220
UMLS 2011AA Property
C0041365
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Physical examination, rectal examination and transrectal ultrasound have been done within 6 months prior to randomization and radiographic studies, if indicated, are negative for metastasis
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient is a suitable candidate for radical prostatectomy or radiotherapy
Description

RadicalProstateTherapyParticipatingInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass
C15368
NCI Metathesaurus ObjectClass
C0439807
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy
Description

NoPriorProstateGlandTherapySurgicalProcedureRadiationTherapyTreatmentRegimenInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C49487
UMLS 2011AA ObjectClass
C1298908
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Metathesaurus Property
C0038895
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No previous androgen deprivation therapy for prostate cancer for greater than 3 months
Description

NoPriorProstateGlandTherapyAndrogenSuppressionTreatmentRegimenInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C49487
UMLS 2011AA ObjectClass
C1298908
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus Property
C15676
UMLS 2011AA Property
C1515985
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
ECOG Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Patient has a minimum life expectancy of > 10 years
Description

PatientLifeExpectancyEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C25359
UMLS 2011AA Property
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has completed the prerandomization quality of life assessment, and is willing to complete future assessments
Description

QOLCompleteAssessmentIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Reason Questionnaire was not Completed
Description

PatientIncompleteQuestionnaireReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
Patient accessible for treatment and follow-up.
Description

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Protocol treatment is to begin within 90 days of randomization
Description

BeginTherapyPostRandomizationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25431
UMLS 2011AA ObjectClass
C0439659
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Planned Date of Treatment Initiation (MM DD YYYY)
Description

TreatmentPlannedBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Ineligibility Criteria
Description

Ineligibility Criteria

Patient has a history of other malignancies except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumours curatively treated with no evidence of disease for >= 5 years from randomization
Description

PatientNeoplasmPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Androgen therapy is planned for this patient except in the context of radical therapy
Description

AndrogenSuppressionTherapyAdministrationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ObjectClass
C15676
UMLS 2011AA ObjectClass
C1515985
For U.s. Patients
Description

For U.s. Patients

Has HIPAA authorization been obtained?
Description

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
Date HIPAA Authorization signed (YYYY MMM DD)
Description

PatientSignedDischargeMedicalRecordDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Stratification Factors
Description

Stratification Factors

ECOG Performance status
Description

PerformanceStatusAssessmentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Stage
Description

PatientTStageProstateAdenocarcinomaClinicalTrialEligibilityCriteriaStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25728
UMLS 2011AA Property
C0475455
NCI Thesaurus Property
C2919
UMLS 2011AA Property
C0007112
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Baseline PSA Value (ng/ml or ug/l)
Description

LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Age
Description

PatientFirstProtocolRegistrationAgeYearCount

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
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National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)

1 forms
  1. StudyEvent: NCIC-PR.11 Eligibility Worksheet Form
    1. National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Eligibility Criteria
Item
Patient has histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization
text
C25458 (NCI Thesaurus ObjectClass)
C0750484 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
C25527 (NCI Thesaurus ObjectClass)
C0205462 (UMLS 2011AA ObjectClass)
C2919 (NCI Thesaurus ObjectClass)
C0007112 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.1
Code List
Patient has histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
NewCancerDiagnosisDate
Item
Date of diagnosis (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item
Clinical T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.2
Code List
Clinical T Stage
CL Item
Tumor Incidental Histologic Finding In More Than 5% Of Tissue Resected (T1b)
CL Item
Tumor Identified By Needle Biopsy (eg, Because Of Elevated Psa) (T1c)
CL Item
Tumor Involves One Lobe (T2a)
CL Item
Tumor Involves Both Lobes (T2b)
Item
Gleason Grade, Score (sum)
double
C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property)
C0449774 (UMLS 2011AA Property)
CL.3
Code List
Gleason Grade, Score (sum)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
PSA <=10.0 ng/ml (ug/L Note: for patients who have received prior treatment with 5-alpha reductase inhibitors 5ARI must adhere to the following criteria: Duration of 5ARI exposure prior to date of baseline PSA Eligible PSA value ng/ml or ug/L < 2 months <= 10.0 2 months-6 months <= 7.0 > 6 months <= 5.0)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.4
Code List
PSA <=10.0 ng/ml (ug/L Note: for patients who have received prior treatment with 5-alpha reductase inhibitors 5ARI must adhere to the following criteria: Duration of 5ARI exposure prior to date of baseline PSA Eligible PSA value ng/ml or ug/L < 2 months <= 10.0 2 months-6 months <= 7.0 > 6 months <= 5.0)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue
Item
PSA Value (total) (ng/ml ug/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Physical examination, rectal examination and transrectal ultrasound have been done within 6 months prior to randomization and radiographic studies, if indicated, are negative for metastasis
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Physical examination, rectal examination and transrectal ultrasound have been done within 6 months prior to randomization and radiographic studies, if indicated, are negative for metastasis
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient is a suitable candidate for radical prostatectomy or radiotherapy
text
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C0439807 (NCI Metathesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.6
Code List
Patient is a suitable candidate for radical prostatectomy or radiotherapy
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
No previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy
text
C49487 (NCI Thesaurus ObjectClass)
C1298908 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C0038895 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.7
Code List
No previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
No previous androgen deprivation therapy for prostate cancer for greater than 3 months
text
C49487 (NCI Thesaurus ObjectClass)
C1298908 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C15676 (NCI Thesaurus Property)
C1515985 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
No previous androgen deprivation therapy for prostate cancer for greater than 3 months
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.9
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
Item
Patient has a minimum life expectancy of > 10 years
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25359 (NCI Thesaurus Property)
C0679138 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.10
Code List
Patient has a minimum life expectancy of > 10 years
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has completed the prerandomization quality of life assessment, and is willing to complete future assessments
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
CL.11
Code List
Patient has completed the prerandomization quality of life assessment, and is willing to complete future assessments
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Reason Questionnaire was not Completed
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)
CL.12
Code List
Reason Questionnaire was not Completed
CL Item
Centre Is Not Participating In The Quality Of Life Component Of The Trial (Centre is not participating in the Quality of Life component of the trial)
CL Item
Unable To Accomodate Disability Or Language Needs (Unable to accomodate disability or language needs)
Item
Patient accessible for treatment and follow-up.
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.13
Code List
Patient accessible for treatment and follow-up.
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Protocol treatment is to begin within 90 days of randomization
text
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ObjectClass)
C0439659 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.14
Code List
Protocol treatment is to begin within 90 days of randomization
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
TreatmentPlannedBeginDate
Item
Planned Date of Treatment Initiation (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
Item Group
Ineligibility Criteria
Item
Patient has a history of other malignancies except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumours curatively treated with no evidence of disease for >= 5 years from randomization
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.15
Code List
Patient has a history of other malignancies except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumours curatively treated with no evidence of disease for >= 5 years from randomization
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Androgen therapy is planned for this patient except in the context of radical therapy
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C15676 (NCI Thesaurus ObjectClass)
C1515985 (UMLS 2011AA ObjectClass)
CL.16
Code List
Androgen therapy is planned for this patient except in the context of radical therapy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
For U.s. Patients
Item
Has HIPAA authorization been obtained?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
CL.17
Code List
Has HIPAA authorization been obtained?
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientSignedDischargeMedicalRecordDate
Item
Date HIPAA Authorization signed (YYYY MMM DD)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Stratification Factors
Item
ECOG Performance status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.18
Code List
ECOG Performance status
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 Or 2 (1 or 2)
Item
Stage
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C2919 (NCI Thesaurus Property)
C0007112 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.19
Code List
Stage
CL Item
T1 (T1)
C1179687 (NCI Metathesaurus)
CL Item
T2 (T2)
Item
Baseline PSA Value (ng/ml or ug/l)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.20
Code List
Baseline PSA Value (ng/ml or ug/l)
CL Item
< 5.0 (< 5.0)
CL Item
>= 5.0 And <= 10.0 (>= 5.0 and <= 10.0)
Item
Age
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CL.21
Code List
Age
CL Item
< 65 (< 65)
CL Item
>= 65 (>= 65)
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