ID

34371

Descrição

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

Link

https://clinicaltrials.gov/show/NCT01512472

Palavras-chave

  1. 16/01/2019 16/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Prostate Cancer Recurrent NCT01512472

Eligibility Prostate Cancer Recurrent NCT01512472

Inclusion Criteria
Descrição

Inclusion Criteria

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

Adenocarcinoma of prostate | Indication Hormone Therapy Intermittent

Tipo de dados

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:
Descrição

PSA Level Criteria Fulfill

Tipo de dados

boolean

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

PSA Level

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Serum testosterone measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428413
Exclusion Criteria
Descrição

Exclusion Criteria

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

Management Hormonal Prostate carcinoma | Surgical castration

Tipo de dados

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
Descrição

5-alpha Reductase Inhibitors | Finasteride | Dutasteride

Tipo de dados

boolean

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

Similar models

Eligibility Prostate Cancer Recurrent NCT01512472

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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