ID

31673

Description

Phase II Study of ASP3550 in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00568516

Link

https://clinicaltrials.gov/show/NCT00568516

Keywords

Versions (1)
  1. 9/19/18 9/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00568516

English

Eligibility Prostatic Neoplasms NCT00568516

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
Description

Adenocarcinoma of prostate TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3258246
is a patient in whom endocrine treatment is indicated. patients with rising serum psa after having prostatectomy or radiotherapy performed with curative intention may be included
Description

Indication Hormone Therapy | Raised prostate specific antigen Post Prostatectomy Curative | Raised prostate specific antigen Post Therapeutic radiology procedure Curative

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0279025
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0033573
UMLS CUI [2,4]
C1276305
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1522449
UMLS CUI [3,4]
C1276305
has a serum testosterone level above 1.5 ng/ml at screening
Description

Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428413
has an ecog (eastern co-operative oncology group) p.s. (performance status) score of 0 to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or present endocrine treatment for prostate cancer. however, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding screening visit may be included
Description

Hormone Therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
is being treated with a 5α-reductase inhibitor
Description

5-alpha Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2936788
is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
Description

Patient Appropriate Curative treatment | Patient Appropriate Radical prostatectomy | Patient Appropriate Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1273390
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0194810
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C1522449
has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
Description

Severe asthma | Patient need for Inhaled steroids Daily | Anaphylaxis | Urticaria Severe | Angioedema

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C2065041
UMLS CUI [2,3]
C0332173
UMLS CUI [3]
C0002792
UMLS CUI [4,1]
C0042109
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0002994
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Similar models

Eligibility Prostatic Neoplasms NCT00568516

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate TNM clinical staging
Item
is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
boolean
C0007112 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Indication Hormone Therapy | Raised prostate specific antigen Post Prostatectomy Curative | Raised prostate specific antigen Post Therapeutic radiology procedure Curative
Item
is a patient in whom endocrine treatment is indicated. patients with rising serum psa after having prostatectomy or radiotherapy performed with curative intention may be included
boolean
C3146298 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0033573 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
C0178415 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1276305 (UMLS CUI [3,4])
Serum testosterone measurement
Item
has a serum testosterone level above 1.5 ng/ml at screening
boolean
C0428413 (UMLS CUI [1])
ECOG performance status
Item
has an ecog (eastern co-operative oncology group) p.s. (performance status) score of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Prostate carcinoma
Item
previous or present endocrine treatment for prostate cancer. however, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding screening visit may be included
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
5-alpha Reductase Inhibitors
Item
is being treated with a 5α-reductase inhibitor
boolean
C2936788 (UMLS CUI [1])
Patient Appropriate Curative treatment | Patient Appropriate Radical prostatectomy | Patient Appropriate Therapeutic radiology procedure
Item
is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
Severe asthma | Patient need for Inhaled steroids Daily | Anaphylaxis | Urticaria Severe | Angioedema
Item
has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
boolean
C0581126 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C2065041 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0002792 (UMLS CUI [3])
C0042109 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0002994 (UMLS CUI [5])
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