Prostate carcinoma Needle biopsy | Prostatectomy | Raised prostate specific antigen | Metastatic Lesion Bone scan
Item
histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). in the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum psa and metastatic lesions on bone scan.
boolean
C0600139 (UMLS CUI [1,1])
C0005560 (UMLS CUI [1,2])
C0033573 (UMLS CUI [2])
C0178415 (UMLS CUI [3])
C1513183 (UMLS CUI [4,1])
C0203668 (UMLS CUI [4,2])
Hormone refractory prostate cancer Progressive | Raised prostate specific antigen | Lesion New Bone scan | Lesion New CT scan | Antiandrogen therapy conventional | Androgen Antagonists Withdrawal | Neoplasm Metastasis CT scan Positive | Neoplasm Metastasis Bone scan
Item
progressive hrpc defined as a psa increase over baseline of >25% or 5ng/ml or new lesions on bone/ct scan after conventional androgen deprivation and antiandrogen withdrawal. evidence of metastatic disease based on positive ct or bone scan is not required.
boolean
C1328504 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0203668 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C0205314 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C0279492 (UMLS CUI [5,1])
C0439858 (UMLS CUI [5,2])
C0002842 (UMLS CUI [6,1])
C2349954 (UMLS CUI [6,2])
C0027627 (UMLS CUI [7,1])
C0040405 (UMLS CUI [7,2])
C1514241 (UMLS CUI [7,3])
C0027627 (UMLS CUI [8,1])
C0203668 (UMLS CUI [8,2])
Prostate specific antigen measurement | total serum testosterone measurement
Item
psa of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
boolean
C0201544 (UMLS CUI [1])
C2210797 (UMLS CUI [2])
Chemotherapy Discontinued
Item
prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Estrogens Discontinued
Item
prior therapy with estrogens is permitted but must have been discontinued > 4 weeks prior to registration
boolean
C0014939 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Bone Marrow function
Item
adequate renal function, hepatic function, and bone marrow function as outlined in protocol
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Electrocardiogram QT interval normal
Item
ecg showing a normal qt interval
boolean
C0853831 (UMLS CUI [1])
Ketoconazole | Adrenal Cortex Hormones | Therapeutic procedure Hormone refractory prostate cancer
Item
prior therapy with ketoconazole or corticosteroids for hrpc
boolean
C0022625 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1328504 (UMLS CUI [3,2])
Major surgery | Therapeutic radiology procedure
Item
major surgery or radiation therapy within 4 weeks
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Strontium-89 | Samarium 153
Item
strontium-89 or samarium-153 therapy within 4 weeks
boolean
C0281385 (UMLS CUI [1])
C0677942 (UMLS CUI [2])
Thromboembolism
Item
thromboembolism in past 6 months
boolean
C0040038 (UMLS CUI [1])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations At risk Torsades de Pointes
Item
patients who are taking drugs that may further prolong qt intervals and present a known risk for torsades de pointes.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
perampanel
Item
concomitant use of drugs known to be narrow therapeutic index ctp3a4
boolean
C2698764 (UMLS CUI [1])
CYP3A4 Substrate Sensitive
Item
drugs that are sensitive cyp3a4 substrates
boolean
C1142644 (UMLS CUI [1,1])
C3891814 (UMLS CUI [1,2])
C0332324 (UMLS CUI [1,3])
Substance Dependence
Item
alcohol or drug dependence currently or in the last 6 months
boolean
C0038580 (UMLS CUI [1])