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)
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)
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)
Code List
Gleason Grade, Score (sum)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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)
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
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)
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
ECOG Performance status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
Code List
ECOG Performance status
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
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 Item
T1 (T1)
C1179687 (NCI Metathesaurus)
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)
Code List
Baseline PSA Value (ng/ml or ug/l)
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)