Age
Item
must be of age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
must have histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Hormone refractory prostate cancer
Item
must have hormone-refractory prostate cancer
boolean
C1328504 (UMLS CUI [1])
docetaxel | First line treatment failed
Item
must have failed first-line docetaxel-containing regimen
boolean
C0246415 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Immunotherapy Absent | Vaccines Absent | GM-CSF Absent
Item
must not have had any prior immunotherapy including, but not limited to, vaccines and gm-csf
boolean
C0021083 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0079460 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Prostate-Specific Antigen Minimum | Raised prostate specific antigen | Progressive Disease Post Androgen suppression | docetaxel | First line treatment Chemotherapy
Item
minimum psa > 5mg/dl, and rising according to the psa consensus criteria (i.e. progressive disease after androgen deprivation and during first-line docetaxel-based chemotherapy)
boolean
C0138741 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1515985 (UMLS CUI [3,3])
C0246415 (UMLS CUI [4])
C1708063 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
Karnofsky Performance Status
Item
kps > 60%
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 6 months
boolean
C0023671 (UMLS CUI [1])
Exclusion Criteria | Hormone Therapy
Item
exclusion criteria:- concomitant hormonal therapy
boolean
C0680251 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Non-compliance
Item
noncompliance
boolean
C0457432 (UMLS CUI [1])
Medicinal Herbs | Prostatic specific antigen decreased
Item
use of herbal products known to decrease psa levels
boolean
C0025125 (UMLS CUI [1])
C0178414 (UMLS CUI [2])
Supplement Use of | Pharmaceutical Preparations Additional | Multivitamin preparation Supplement conventional | Selenium | lycopene | Soy | Vitamin E
Item
use of supplements or complementary medicines, except for conventional multivitamin supplements, selenium, lycopene, soy supplements, vitamin e
boolean
C2348609 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0301532 (UMLS CUI [3,1])
C2348609 (UMLS CUI [3,2])
C0439858 (UMLS CUI [3,3])
C0521939 (UMLS CUI [4])
C0065331 (UMLS CUI [5])
C2756587 (UMLS CUI [6])
C0042874 (UMLS CUI [7])
Diphosphonates
Item
initiation of bisphosphonates within one month prior to enrollment or throughout the study
boolean
C0012544 (UMLS CUI [1])
Radiopharmaceuticals | Strontium | Samarium
Item
any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
boolean
C0182638 (UMLS CUI [1])
C0038467 (UMLS CUI [2])
C0036147 (UMLS CUI [3])
major surgery | Therapeutic radiology procedure
Item
major surgery or radiation therapy completed <4 weeks prior to enrollment
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Neoplasms, Second | Skin carcinoma
Item
any concomitant second malignancy other than non-melanoma skin cancer
boolean
C0085183 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Communicable Disease Serious | Illness Non-Malignant Serious
Item
any concomitant serious infection or nonmalignant medical illness
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
anc < 1,500/µl, platelet count <100,000/µl, hemoglobin < 8 mg/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Elevated total bilirubin
Item
total bilirubin greater than 1.5 x ulrr
boolean
C0741494 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Secondary malignant neoplasm of liver
Item
alt or ast greater than 2.5 x ulrr if no demonstrable liver metastases or greater than 5.0 x ulrr in presence of liver metastases
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0494165 (UMLS CUI [3])