Informed Consent
Item
1. provision of written informed consent.
boolean
C0021430 (UMLS CUI [1])
Gender | Age | Prostate carcinoma
Item
2. men, over 18 years of age, with histologically-confirmed prostate cancer
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0600139 (UMLS CUI [3])
Zoladex | Goserelin Acetate
Item
3. treatment with zoladex (goserelin acetate) for greater than 3 months prior to day 1
boolean
C0149473 (UMLS CUI [1])
C0700476 (UMLS CUI [2])
Serum testosterone measurement
Item
4. serum testosterone level < 50 ng/ml
boolean
C0428413 (UMLS CUI [1])
Bicalutamide U/day
Item
5. current treatment with bicalutamide 50 mg daily.**
boolean
C0285590 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Raised prostate specific antigen Findings Quantity | Prostate specific antigen measurement Most Recent Absolute value
Item
6. two consecutive rises in psa above a nadir value, with the absolute value of the latest psa > 2.0 ng/ml.
boolean
C0178415 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0201544 (UMLS CUI [2,1])
C1513491 (UMLS CUI [2,2])
C0205344 (UMLS CUI [2,3])
Prostate specific antigen measurement Highest
Item
7. highest psa level no greater than or equal to 30 ng/ml.
boolean
C0201544 (UMLS CUI [1,1])
C1522410 (UMLS CUI [1,2])
Life Expectancy
Item
8. life expectancy of greater than 1 year -
boolean
C0023671 (UMLS CUI [1])
Antiandrogen therapy Prolonged | bicalutamide | Nonsteroidal Anti-Androgens short-term
Item
1. patients may not have received prolonged anti-androgen therapy other than with bicalutamide. patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.*
boolean
C0279492 (UMLS CUI [1,1])
C0439590 (UMLS CUI [1,2])
C0285590 (UMLS CUI [2])
C1320169 (UMLS CUI [3,1])
C0443303 (UMLS CUI [3,2])
Prostate specific antigen measurement
Item
2. psa level greater than 30 ng/ml.
boolean
C0201544 (UMLS CUI [1])
Systemic disease Severe Study Subject Participation Status Inappropriate | Systemic disease Uncontrolled Study Subject Participation Status Inappropriate
Item
3. in the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1548788 (UMLS CUI [2,4])
Chemotherapy
Item
4. subjects who have received prior chemotherapy.
boolean
C0392920 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma | Transitional cell carcinoma of bladder Superficial
Item
5. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0279680 (UMLS CUI [3,1])
C0205124 (UMLS CUI [3,2])
Absolute neutrophil count | Platelet Count measurement
Item
6. absolute neutrophil count less than 1.5 x 109/l or platelets less than 100 x 109/l.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Elevated total bilirubin
Item
7. serum bilirubin greater than 1.25 times the upper limit of reference range (ulrr).
boolean
C0741494 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
8. alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 2.5 times the ulrr.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Serum creatinine raised
Item
9. serum creatinine greater than 1.5 times -
boolean
C0700225 (UMLS CUI [1])