Age
Item
age ≥ 65 years;
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate;
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis
Item
metastatic disease;
boolean
C0027627 (UMLS CUI [1])
Hormone Therapy refractory | Measurable Disease 2-Dimensional Progressing | Evaluable Disease Progressing Scan of bone | Raised prostate specific antigen Quantity
Item
unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: progression of bidimensionally measurable disease; progression of evaluable but not measurable disease (bone scan); at least 2 consecutive rises in psa at least 1 week apart;
boolean
C0279025 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C0205329 (UMLS CUI [2,3])
C1516986 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
C0203668 (UMLS CUI [3,3])
C0178415 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Serum testosterone measurement | Medical Castration | Luteinizing Hormone-releasing Hormone Agonist | Testicular ablation
Item
patients must have serum testosterone levels < 50 ng/ml at time of study entry. for patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression;
boolean
C0428413 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C1518041 (UMLS CUI [3])
C1298674 (UMLS CUI [4])
Nonsteroidal Anti-Androgens | Flutamide | Ketoconazole | bicalutamide | nilutamide | Disease Progression | Response Post Androgen Antagonists Withdrawal
Item
prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred. no evidence of response after antiandrogen withdrawal within 4 weeks for patients treated with flutamide, ketoconazole, nilutamide and 6 weeks for patients treated with bicalutamide;
boolean
C1320169 (UMLS CUI [1])
C0016384 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
C0285590 (UMLS CUI [4])
C0068771 (UMLS CUI [5])
C0242656 (UMLS CUI [6])
C1704632 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C0002842 (UMLS CUI [7,3])
C2349954 (UMLS CUI [7,4])
Chemotherapy naive
Item
chemotherapy naïve;
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Effect Operative Surgical Procedures | Effect Therapeutic radiology procedure | Patient Recovered
Item
full recovery from the effects of any prior surgery or radiation therapy. at least 4 weeks since any radiation therapy;
boolean
C1280500 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1280500 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status 0-2;
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Bone Marrow function
Item
adequate kidney, liver, and bone marrow functions;
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Informed Consent
Item
signed study-specific informed consent form.
boolean
C0021430 (UMLS CUI [1])
Chemotherapy | Immunotherapy
Item
concurrent chemotherapy or immunotherapy;
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Investigational New Drugs
Item
patients who have received an investigational drug within 4 weeks of registration;
boolean
C0013230 (UMLS CUI [1])
Malignant Neoplasms | Operative Surgical Procedure Carcinoma in situ of uterine cervix | Operative Surgical Procedure Squamous cell carcinoma of skin | Operative Surgical Procedure Basal cell carcinoma
Item
prior or concurrent malignancies (other than surgically treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin) within the preceding five years;
boolean
C0006826 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
Illness Serious Preventing Informed Consent | Mental disorder Serious Preventing Informed Consent
Item
serious medical or psychiatric illness which would prevent informed consent;
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
Life Expectancy
Item
life expectancy < 3 months;
boolean
C0023671 (UMLS CUI [1])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled
Item
active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled;
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Polysorbate 80 Formulation
Item
known hypersensitivity to study drug or to other drugs formulated with polysorbate 80.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C1705957 (UMLS CUI [2,3])