Adenocarcinoma of the prostate metastatic Progressive Androgen-independent | Disease Radiography
Item
patients with histologically confirmed progressive metastatic androgen-independent adenocarcinoma of the prostate with radiographic evidence of disease.
boolean
C0862636 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C2986466 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
Cytotoxic Chemotherapy Quantity
Item
no more than two previous cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Castration Levels of Testosterone | Orchiectomy | Gonadotropin Releasing Hormone Agonist
Item
castration level of testosterone (< 50 ng/dl) achieved by orchiectomy or gonadotropin-releasing hormone(gnrh) agonist
boolean
C4289828 (UMLS CUI [1])
C0029189 (UMLS CUI [2])
C2267073 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group(ecog) performance status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Investigational New Drugs Treatment completed | Chemotherapy Completed
Item
finished any study drug or chemotherapy earlier than 4 weeks before the first administration of the study drug.
boolean
C0013230 (UMLS CUI [1,1])
C0580352 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Age
Item
age ≥ 20 years old
boolean
C0001779 (UMLS CUI [1])
Laboratory Results Required
Item
patients must have the following laboratory values:
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥ 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥ 75 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin (hgb) > 8 g/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum total bilirubin: ≤ 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of liver Absent
Item
alanine transaminase(alt) and aspartate aminotransferase(ast) ≤ 2.0 x upper limit of normal(uln) with or without liver metastases
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0494165 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 x uln or serum creatinine >1.5 - 3 x uln or 1.5 x uln<serum creatinine < 3 x uln, if calculated creatinine clearance (crcl) is ≥
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
30 ml/min using the cockcroft-gault equation, see formula below:
boolean
C2711451 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Gender
Item
crcl = [140-age (years)] x weight (kg) / [72 x serum cr (mg/dl)] (if patient is female multiply the above by 0.85)
boolean
C2711451 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Informed Consent
Item
patients who give a written informed consent obtained according to local guidelines
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Any
Item
patients eligible for this study must not meet any of the following criteria
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Absent
Item
patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
boolean
C0220650 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C3897780 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma Treated | Exception Skin carcinoma Treated
Item
patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or non-melanomatous skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007137 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699893 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])