testosterone, androgen deprivation
Item
testosterone < 50 ng/dl. patients must continue primary androgen deprivation with an lhrh analogue if they have not undergone orchiectomy.
boolean
C0039601 (UMLS CUI [1])
C0279492 (UMLS CUI [2])
progressive disease after androgen deprivation
Item
progressive disease after androgen deprivation.
boolean
C1335499 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
antiandrogen discontinuation disease progression
Item
patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen.
boolean
C0002842 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,3])
karnofsky performance status
Item
karnofsky performance status ≥ 60%.
boolean
C0206065 (UMLS CUI [1])
prostate cancer taxane based chemotherapy
Item
one prior taxane based chemotherapy for prostate cancer. no more than two prior systemic therapies. at least four weeks have lapsed since prior therapy.
boolean
C0600139 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C3541958 (UMLS CUI [1,3])
ketoconazole, aminoglutethimide, corticosteroids
Item
patients may have had prior ketoconazole, aminoglutethimide or corticosteroids for treatment of progressive prostate cancer.
boolean
C0022625 (UMLS CUI [1])
C0002555 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
hormonal therapy, progressive disease documentation
Item
patients receiving any other hormonal therapy, including any dose of megestrol acetate (megace), proscar (finasteride), any herbal product known to decrease psa levels (e.g., saw palmetto and pc-spes), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment. progressive disease must be documented after discontinuation of the hormonal therapy.
boolean
C0279025 (UMLS CUI [1])
C0677932 (UMLS CUI [2,1])
C0920316 (UMLS CUI [2,2])
bisphosphonates
Item
patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
boolean
C0012544 (UMLS CUI [1])
liver function
Item
liver function tests (alt, ast) less than 1.5 x upper limit of normal (uln). the bilirubin must be within normal limits.
boolean
C0232741 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,3])
C0201899 (UMLS CUI [1,4])
anc, platelet count, creatinine, hemoglobin
Item
anc >1500/µl, platelet count > 100,00/µl, creatinine <1.5 x uln, hemoglobin > 8 mg/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
cardiac ejection fraction
Item
ejection fraction ≥45%.
boolean
C0232174 (UMLS CUI [1])