ID

44318

Description

A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02405858

Link

https://clinicaltrials.gov/show/NCT02405858

Keywords

Versions (2)
  1. 5/9/19 5/9/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Castration-Resistant Prostate Cancer NCT02405858

English

Eligibility Metastatic Castration-Resistant Prostate Cancer NCT02405858

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants who have histologically or cytologically confirm adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
Description

Adenocarcinoma of prostate Without Neuroendocrine Differentiation | Adenocarcinoma of prostate Non-small cell

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C1709218
UMLS CUI [2,1]
C0007112
UMLS CUI [2,2]
C0445128
participants who had prostate-specific antigen (psa) progression defined as a rise of psa at least 1 week apart resulting in 25 percent (%) increase in psa with last psa greater than (>) 2 nanogram per milliliter (ng/ml) (according to pcwg2) after antiandrogen withdrawal
Description

Raised prostate specific antigen Percentage | Status post Antiandrogen Withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0002842
UMLS CUI [2,3]
C2349954
participants who had psa progression within a year after the start of first-line cab therapy, or who had psa progression without having a normal psa level (less than [<] 4.0 ng/ml) in the first-line combined androgen blockade (cab) therapy
Description

Raised prostate specific antigen | Status post First line treatment Combined androgen blockade | Prostate specific antigen abnormal During Combined androgen blockade

Data type

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C3495882
UMLS CUI [3,1]
C0580555
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C3495882
participants who have not been treated with cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer (neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is greater than or equal to [>=] 1 year from the scheduled date of initial administration of abiraterone acetate)
Description

Cytotoxic Chemotherapy Absent Prostate carcinoma | Estramustine Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C0014921
UMLS CUI [2,2]
C0332197
participants who have target or non-target metastatic abnormalities either on screening bone scan, computed tomography (ct) or magnetic resonance imaging (mri)
Description

Target Neoplasm Metastasis Bone scan | Neoplasm Metastasis Non-Target Bone scan | Target Neoplasm Metastasis CT | Neoplasm Metastasis Non-Target CT | Target Neoplasm Metastasis MRI | Neoplasm Metastasis Non-Target MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0203668
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1518389
UMLS CUI [2,3]
C0203668
UMLS CUI [3,1]
C1521840
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C1518389
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C1521840
UMLS CUI [5,2]
C0027627
UMLS CUI [5,3]
C0024485
UMLS CUI [6,1]
C0027627
UMLS CUI [6,2]
C1518389
UMLS CUI [6,3]
C0024485
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a participant who has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients
Description

Hypersensitivity Abiraterone acetate | Intolerance to Abiraterone acetate | Hypersensitivity Abiraterone acetate Excipient | Intolerance to Abiraterone acetate Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2607886
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C2607886
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2607886
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C2607886
UMLS CUI [4,3]
C0015237
a participant who has severe liver dysfunction (child-pugh score c), active or symptomatic viral hepatitis or chronic liver disease
Description

Liver Dysfunction Severe Child-Pugh Classification | Viral hepatitis | Viral hepatitis Symptomatic | Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4050412
UMLS CUI [2]
C0042721
UMLS CUI [3,1]
C0042721
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0341439
a participant who has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease psa levels (example: saw palmetto and pc-spes) within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
Description

Hormone Therapy | Finasteride Dose Any | Dutasteride Dose Any | Herbal product Decreasing PSA Level | Saw palmetto extract | PC-SPES

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0060389
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1552551
UMLS CUI [3,1]
C0754659
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1552551
UMLS CUI [4,1]
C2240391
UMLS CUI [4,2]
C0442797
UMLS CUI [4,3]
C4086720
UMLS CUI [5]
C0771607
UMLS CUI [6]
C0756934
a participant who has had surgery or local prostatic intervention within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
Description

Operative Surgical Procedures | Intervention Prostatic Local

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1522721
UMLS CUI [2,3]
C0205276
a participant who has active infection or other medical condition that would make prednisolone use contraindicated
Description

Communicable Disease | Other medical condition Prednisolone Contraindicated

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0032950
UMLS CUI [2,3]
C1444657
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Similar models

Eligibility Metastatic Castration-Resistant Prostate Cancer NCT02405858

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate Without Neuroendocrine Differentiation | Adenocarcinoma of prostate Non-small cell
Item
participants who have histologically or cytologically confirm adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
boolean
C0007112 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C1709218 (UMLS CUI [1,3])
C0007112 (UMLS CUI [2,1])
C0445128 (UMLS CUI [2,2])
Raised prostate specific antigen Percentage | Status post Antiandrogen Withdrawal
Item
participants who had prostate-specific antigen (psa) progression defined as a rise of psa at least 1 week apart resulting in 25 percent (%) increase in psa with last psa greater than (>) 2 nanogram per milliliter (ng/ml) (according to pcwg2) after antiandrogen withdrawal
boolean
C0178415 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0002842 (UMLS CUI [2,2])
C2349954 (UMLS CUI [2,3])
Raised prostate specific antigen | Status post First line treatment Combined androgen blockade | Prostate specific antigen abnormal During Combined androgen blockade
Item
participants who had psa progression within a year after the start of first-line cab therapy, or who had psa progression without having a normal psa level (less than [<] 4.0 ng/ml) in the first-line combined androgen blockade (cab) therapy
boolean
C0178415 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C3495882 (UMLS CUI [2,3])
C0580555 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C3495882 (UMLS CUI [3,3])
Cytotoxic Chemotherapy Absent Prostate carcinoma | Estramustine Absent
Item
participants who have not been treated with cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer (neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is greater than or equal to [>=] 1 year from the scheduled date of initial administration of abiraterone acetate)
boolean
C0677881 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0014921 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Target Neoplasm Metastasis Bone scan | Neoplasm Metastasis Non-Target Bone scan | Target Neoplasm Metastasis CT | Neoplasm Metastasis Non-Target CT | Target Neoplasm Metastasis MRI | Neoplasm Metastasis Non-Target MRI
Item
participants who have target or non-target metastatic abnormalities either on screening bone scan, computed tomography (ct) or magnetic resonance imaging (mri)
boolean
C1521840 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C1518389 (UMLS CUI [2,2])
C0203668 (UMLS CUI [2,3])
C1521840 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C1518389 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C1521840 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
C0027627 (UMLS CUI [6,1])
C1518389 (UMLS CUI [6,2])
C0024485 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Abiraterone acetate | Intolerance to Abiraterone acetate | Hypersensitivity Abiraterone acetate Excipient | Intolerance to Abiraterone acetate Excipient
Item
a participant who has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C2607886 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2607886 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2607886 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C2607886 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Liver Dysfunction Severe Child-Pugh Classification | Viral hepatitis | Viral hepatitis Symptomatic | Chronic liver disease
Item
a participant who has severe liver dysfunction (child-pugh score c), active or symptomatic viral hepatitis or chronic liver disease
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
C0042721 (UMLS CUI [2])
C0042721 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0341439 (UMLS CUI [4])
Hormone Therapy | Finasteride Dose Any | Dutasteride Dose Any | Herbal product Decreasing PSA Level | Saw palmetto extract | PC-SPES
Item
a participant who has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease psa levels (example: saw palmetto and pc-spes) within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
boolean
C0279025 (UMLS CUI [1])
C0060389 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0754659 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1552551 (UMLS CUI [3,3])
C2240391 (UMLS CUI [4,1])
C0442797 (UMLS CUI [4,2])
C4086720 (UMLS CUI [4,3])
C0771607 (UMLS CUI [5])
C0756934 (UMLS CUI [6])
Operative Surgical Procedures | Intervention Prostatic Local
Item
a participant who has had surgery or local prostatic intervention within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
boolean
C0543467 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C1522721 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
Communicable Disease | Other medical condition Prednisolone Contraindicated
Item
a participant who has active infection or other medical condition that would make prednisolone use contraindicated
boolean
C0009450 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0032950 (UMLS CUI [2,2])
C1444657 (UMLS CUI [2,3])
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