Gender | Age
Item
patient is male and at least 18 years of age, at the time of screening;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Neoplasm Metastasis TNM clinical staging
Item
patient has metastatic disease (any t, any n, m1);
boolean
C0027627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Taxane Regimen Quantity failed | CRPC Symptomatic | CRPC Asymptomatic | Chemotherapy naive
Item
patient has failed at least 1 taxane regimen; or patient has symptomatic or asymptomatic crpc and is chemotherapy-naïve
boolean
C0215136 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C1328504 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1328504 (UMLS CUI [3,1])
C0231221 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0919936 (UMLS CUI [4,2])
Adenocarcinoma of prostate
Item
patient has histologically or cytologically confirmed adenocarcinoma of the prostate;
boolean
C0007112 (UMLS CUI [1])
Disease Progression | Hormone Therapy
Item
patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following:
boolean
C0242656 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Prostate specific antigen measurement | Raised prostate specific antigen Quantity
Item
psa level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart.
boolean
C0201544 (UMLS CUI [1])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Evaluable Disease Progression
Item
evaluable disease progression by modified recist (response evaluation criteria in solid tumors) criteria;
boolean
C1516986 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Secondary malignant neoplasm of bone Progression Bone scan | Lesion New Quantity Bone scan
Item
progression of metastatic bone disease on bone scan with > 2 new lesions
boolean
C0153690 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0203668 (UMLS CUI [2,4])
ECOG performance status
Item
patient has ecog (eastern cooperative oncology group) performance status of 0-2;
boolean
C1520224 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Parenchymal Symptomatic | Epidural space Disease Requirement Whole brain radiation therapy | Epidural space Disease Treated allowed
Item
patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation treated epidural disease is allowed
boolean
C0220650 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0228134 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1520143 (UMLS CUI [2,4])
C0228134 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
Communicable Disease
Item
patient has active infection;
boolean
C0009450 (UMLS CUI [1])
Cardiovascular Disease | Congestive heart failure | Liver Dysfunction | Respiratory abnormality | Abnormal renal function
Item
patient having a history of clinically significant cardiovascular disease (such as chf), clinically significant hepatic, respiratory or renal abnormalities;
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C4018871 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
Laboratory test result abnormal
Item
patient who has any clinically significant abnormalities in laboratory results at screening
boolean
C0438215 (UMLS CUI [1])
Nervous system disorder | Mental condition Clinical Significance
Item
patient who has a history of clinically significant neurological or psychiatric condition;
boolean
C0027765 (UMLS CUI [1])
C3840291 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Criteria Additional | Cohort Expanded
Item
additional criteria are applicable to expansion cohorts.
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0599755 (UMLS CUI [2,1])
C0205229 (UMLS CUI [2,2])