ID

36564

Description

Open-label, Multi-Centre Trial Investigating Pharmacokinetics of Degarelix After a Starting Dose of 240 mg (40 mg/mL) Followed by Six Maintenance Doses of 80 mg (20 mg/mL) in Chinese Patients With Prostate Cancer Requiring Androgen Deprivation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02468284

Link

https://clinicaltrials.gov/show/NCT02468284

Keywords

Versions (2)
  1. 1/19/19 1/19/19 -
  2. 5/22/19 5/22/19 -
Copyright Holder

Ferring Pharmaceuticals

Uploaded on

May 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Pharmacokinetics of Degarelix in Prostate Cancer NCT02468284

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has a histologically confirmed (gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated
Description

Histologically confirmed (gleason graded) adenocarcinoma of prostate for which endocrine therapy (except neoadjuvant hormonal therapy) is indicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0007112
UMLS CUI [2]
C0332326
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0279025
UMLS CUI [4,1]
C2828389
UMLS CUI [4,2]
C0279025
UMLS CUI [4,3]
C0600558
has a prostate-specific antigen (PSA) level ≥2.0 ng/ml at screening
Description

PSA level

Data type

boolean

Alias
UMLS CUI [1]
C0201544
has a screening serum testosterone level >150 ng/dl
Description

serum testosterone level

Data type

boolean

Alias
UMLS CUI [1]
C0428413
has an eastern cooperative oncology group (ECOG) score of ≤2
Description

ECOG score

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has had previous or is currently under hormonal management of prostate cancer. however, hormonal therapy for a maximum duration of 6 months is accepted. this treatment should have been terminated at least 6 months prior to the screening visit
Description

previous or current hormonal management of prostate cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0521116
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0007112
UMLS CUI [2,3]
C0279025
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0871548
UMLS CUI [3,4]
C0279025
UMLS CUI [3,5]
C0439801
UMLS CUI [3,6]
C0449238
is currently treated with a 5-alpha reductase inhibitor
Description

currently treated with a 5-alpha reductase inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C1318898
UMLS CUI [1,2]
C0521116
is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
Description

considered a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332149
UMLS CUI [1,2]
C1273390
UMLS CUI [2]
C0194810
UMLS CUI [3]
C1522449
is in need of neoadjuvant hormonal therapy
Description

in need of neoadjuvant hormonal therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0600558
has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
Description

history of bilateral orchiectomy, adrenalectomy, or hypophysectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0194875
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0001632
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0020632
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Histologically confirmed (gleason graded) adenocarcinoma of prostate for which endocrine therapy (except neoadjuvant hormonal therapy) is indicated
Item
has a histologically confirmed (gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated
boolean
C0679557 (UMLS CUI [1,1])
C0007112 (UMLS CUI [1,2])
C0332326 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
C2828389 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0600558 (UMLS CUI [4,3])
PSA level
Item
has a prostate-specific antigen (PSA) level ≥2.0 ng/ml at screening
boolean
C0201544 (UMLS CUI [1])
serum testosterone level
Item
has a screening serum testosterone level >150 ng/dl
boolean
C0428413 (UMLS CUI [1])
ECOG score
Item
has an eastern cooperative oncology group (ECOG) score of ≤2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
previous or current hormonal management of prostate cancer
Item
has had previous or is currently under hormonal management of prostate cancer. however, hormonal therapy for a maximum duration of 6 months is accepted. this treatment should have been terminated at least 6 months prior to the screening visit
boolean
C0007112 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0007112 (UMLS CUI [2,2])
C0279025 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0871548 (UMLS CUI [3,3])
C0279025 (UMLS CUI [3,4])
C0439801 (UMLS CUI [3,5])
C0449238 (UMLS CUI [3,6])
currently treated with a 5-alpha reductase inhibitor
Item
is currently treated with a 5-alpha reductase inhibitor
boolean
C1318898 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
considered a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
Item
is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
boolean
C0332149 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C0194810 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
in need of neoadjuvant hormonal therapy
Item
is in need of neoadjuvant hormonal therapy
boolean
C3146298 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
Item
has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
boolean
C0262926 (UMLS CUI [1,1])
C0194875 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0001632 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0020632 (UMLS CUI [3,2])
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