ID

34371

Description

Firmagon (Degarelix) Intermittent Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01512472

Link

https://clinicaltrials.gov/show/NCT01512472

Keywords

Versions (1)
  1. 1/16/19 1/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer Recurrent NCT01512472

English

Eligibility Prostate Cancer Recurrent NCT01512472

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated
Description

Adenocarcinoma of prostate | Indication Hormone Therapy Intermittent

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0279025
UMLS CUI [2,3]
C0205267
psa level meeting both of these criteria:
Description

PSA Level Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C4086720
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
psa level of ≥ 5 ng/ml.
Description

PSA Level

Data type

boolean

Alias
UMLS CUI [1]
C4086720
for patients with recurrence after radiotherapy or cryotherapy: patients should have a serum psa (two measurements) to be >2 ng/ml higher than a previously confirmed psa nadir.
Description

Recurrence Post Therapeutic radiology procedure | Recurrence Post Cold Therapy | Prostate specific antigen measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2825055
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1522449
UMLS CUI [2,1]
C2825055
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0010412
UMLS CUI [3,1]
C0201544
UMLS CUI [3,2]
C1265611
screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/ml.
Description

Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428413
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)
Description

Management Hormonal Prostate carcinoma | Surgical castration

Data type

boolean

Alias
UMLS CUI [1,1]
C0376636
UMLS CUI [1,2]
C0458083
UMLS CUI [1,3]
C0600139
UMLS CUI [2]
C0007344
has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening
Description

5-alpha Reductase Inhibitors | Finasteride | Dutasteride

Data type

boolean

Alias
UMLS CUI [1]
C2936788
UMLS CUI [2]
C0060389
UMLS CUI [3]
C0754659
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Similar models

Eligibility Prostate Cancer Recurrent NCT01512472

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Indication Hormone Therapy Intermittent
Item
histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated
boolean
C0007112 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0205267 (UMLS CUI [2,3])
PSA Level Criteria Fulfill
Item
psa level meeting both of these criteria:
boolean
C4086720 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
PSA Level
Item
psa level of ≥ 5 ng/ml.
boolean
C4086720 (UMLS CUI [1])
Recurrence Post Therapeutic radiology procedure | Recurrence Post Cold Therapy | Prostate specific antigen measurement Quantity
Item
for patients with recurrence after radiotherapy or cryotherapy: patients should have a serum psa (two measurements) to be >2 ng/ml higher than a previously confirmed psa nadir.
boolean
C2825055 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C2825055 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0010412 (UMLS CUI [2,3])
C0201544 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Serum testosterone measurement
Item
screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/ml.
boolean
C0428413 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Management Hormonal Prostate carcinoma | Surgical castration
Item
has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)
boolean
C0376636 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0007344 (UMLS CUI [2])
5-alpha Reductase Inhibitors | Finasteride | Dutasteride
Item
has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening
boolean
C2936788 (UMLS CUI [1])
C0060389 (UMLS CUI [2])
C0754659 (UMLS CUI [3])
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