Adenocarcinoma of prostate
Item
histologically or cytologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Gender | Age
Item
male subjects of age ≥ 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Progression of prostate cancer Prostate specific antigen measurement | Progression of prostate cancer Radiology
Item
prostate cancer progression documented by prostate specific antigen according to the prostate cancer working group 2 (pcwg2) criteria or radiological progression according to response evaluation criteria in solid tumors (recist), version 1.1.
boolean
C1739135 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1739135 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
Secondary malignant neoplasm of bone Quantity Bone scan | Secondary malignant neoplasm of lung Absent | Secondary malignant neoplasm of liver Absent | Neoplasm Metastasis Visceral Absent | Metastatic malignant neoplasm to brain Absent
Item
two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis.
boolean
C0153690 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0153676 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0442045 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0220650 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Prostate carcinoma Asymptomatic | Prostate carcinoma Mild Symptomatic
Item
asymptomatic or mildly symptomatic prostate cancer.
boolean
C0600139 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
Combined androgen blockade | Androgen Antagonists | Raised prostate specific antigen | Status post Androgen Antagonists Discontinued
Item
subjects who received combined androgen blockade with an anti-androgen must have shown psa(prostate specific antigen) progression after discontinuing the anti-androgen prior to enrollment.
boolean
C3495882 (UMLS CUI [1])
C0002842 (UMLS CUI [2])
C0178415 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0002842 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
Medical Castration | Male Castration | Testosterone measurement
Item
medical or surgical castration with testosterone less than 50 ng/dl (1.7nmol/l).
boolean
C1513054 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0523912 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Cytotoxic Chemotherapy Hormone refractory prostate cancer | Taxanes | Mitoxantrone | Estramustine
Item
prior cytotoxic chemotherapy for the treatment of crpc, including taxanes, mitoxantrone and estramustine
boolean
C0677881 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
C0796419 (UMLS CUI [2])
C0026259 (UMLS CUI [3])
C0014921 (UMLS CUI [4])
Chronic disease Requirement Adrenal Cortex Hormones Dose
Item
any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
Pathology Consistent with Small cell carcinoma of prostate
Item
pathological finding consistent with small cell carcinoma of the prostate
boolean
C0677042 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C1300585 (UMLS CUI [1,3])
Neoplasm Metastasis Visceral
Item
history of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
history of or known brain metastasis.
boolean
C0220650 (UMLS CUI [1])
Lymphadenopathy Malignant | Diameter Short axis
Item
malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
boolean
C0497156 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2,1])
C0522488 (UMLS CUI [2,2])
Blood Transfusion | Pharmaceutical Preparations Stimulation Erythropoietin
Item
blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization
boolean
C0005841 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1292856 (UMLS CUI [2,2])
C0014822 (UMLS CUI [2,3])
Signs and Symptoms Compression of spinal cord Impending | Compression of spinal cord Impending MRI
Item
imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (mri). subjects with history of spinal cord compression should have completely recovered
boolean
C0037088 (UMLS CUI [1,1])
C0037926 (UMLS CUI [1,2])
C0332190 (UMLS CUI [1,3])
C0037926 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Opiate Analgesics Cancer Pain | Codeine | Propoxyphene
Item
use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization.
boolean
C0376196 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
C0596240 (UMLS CUI [1,3])
C0009214 (UMLS CUI [2])
C0033493 (UMLS CUI [3])