ID

22694

Description

Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT00554086

Link

https://clinicaltrials.gov/show/NCT00554086

Keywords

Versions (1)
  1. 6/9/17 6/9/17 -
Uploaded on

June 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00554086

English

Eligibility Prostate Cancer NCT00554086

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. men, over 18 years of age, with histologically-confirmed prostate cancer
Description

Gender | Age | Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0600139
3. treatment with zoladex (goserelin acetate) for greater than 3 months prior to day 1
Description

Zoladex | Goserelin Acetate

Data type

boolean

Alias
UMLS CUI [1]
C0149473
UMLS CUI [2]
C0700476
4. serum testosterone level < 50 ng/ml
Description

Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428413
5. current treatment with bicalutamide 50 mg daily.**
Description

Bicalutamide U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0285590
UMLS CUI [1,2]
C0456683
6. two consecutive rises in psa above a nadir value, with the absolute value of the latest psa > 2.0 ng/ml.
Description

Raised prostate specific antigen Findings Quantity | Prostate specific antigen measurement Most Recent Absolute value

Data type

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C2607943
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0201544
UMLS CUI [2,2]
C1513491
UMLS CUI [2,3]
C0205344
7. highest psa level no greater than or equal to 30 ng/ml.
Description

Prostate specific antigen measurement Highest

Data type

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C1522410
8. life expectancy of greater than 1 year -
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.*
Description

Antiandrogen therapy Prolonged | bicalutamide | Nonsteroidal Anti-Androgens short-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0439590
UMLS CUI [2]
C0285590
UMLS CUI [3,1]
C1320169
UMLS CUI [3,2]
C0443303
2. psa level greater than 30 ng/ml.
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
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.
Description

Systemic disease Severe Study Subject Participation Status Inappropriate | Systemic disease Uncontrolled Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1548788
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1548788
4. subjects who have received prior chemotherapy.
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
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.
Description

Malignant Neoplasms | Basal cell carcinoma | Transitional cell carcinoma of bladder Superficial

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3,1]
C0279680
UMLS CUI [3,2]
C0205124
6. absolute neutrophil count less than 1.5 x 109/l or platelets less than 100 x 109/l.
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
7. serum bilirubin greater than 1.25 times the upper limit of reference range (ulrr).
Description

Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0741494
8. alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 2.5 times the ulrr.
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
9. serum creatinine greater than 1.5 times -
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
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Similar models

Eligibility Prostate Cancer NCT00554086

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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