ID

36098

Description

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK); ODM derived from: https://clinicaltrials.gov/show/NCT02319837

Link

https://clinicaltrials.gov/show/NCT02319837

Keywords

Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hormone Sensitive Prostate Cancer NCT02319837

English

Eligibility Hormone Sensitive Prostate Cancer NCT02319837

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
Description

Adenocarcinoma of prostate Biopsy | Neuroendocrine Differentiation Absent | Signet ring cell Absent | Absence Feature Cells Small

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C1709218
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0333727
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2348519
UMLS CUI [4,3]
C0007634
UMLS CUI [4,4]
C0700321
prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
Description

Radical prostatectomy Curative intent Prostate carcinoma | Therapeutic radiology procedure Curative intent Prostate carcinoma | Brachytherapy Curative intent Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C1276305
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1276305
UMLS CUI [2,3]
C0600139
UMLS CUI [3,1]
C0006098
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C0600139
psa doubling time ≤ 9 months;
Description

PSA Doubling Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C2986483
screening psa ≥ 2.0 ng/ml for patients who had radical prostatectomy as primary treatment for prostate cancer or ≥ 5.0 ng/ml and greater than or equal to the nadir +
Description

Prostate specific antigen measurement | Radical prostatectomy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0194810
UMLS CUI [2,2]
C0600139
2 ng/ml for patients who had radiotherapy as primary treatment for prostate cancer;
Description

Therapeutic radiology procedure Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0600139
serum testosterone ≥ 150 ng/dl (5.2 nmol/l).
Description

Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428413
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
Description

Distant metastasis Radiographic imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0457276
prior hormonal therapy other than neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization;
Description

Prior Hormone Therapy Prostate carcinoma | Exception Neoadjuvant Therapy | Exception Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0677850
prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
Description

Cytotoxic Chemotherapy Prostate carcinoma | Aminoglutethimide | Ketoconazole | abiraterone acetate | enzalutamide

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0002555
UMLS CUI [3]
C0022625
UMLS CUI [4]
C2607886
UMLS CUI [5]
C3496793
prior systemic biologic therapy, including immunotherapy, for prostate cancer;
Description

Biological treatment Systemic Prostate carcinoma | Prior Immunotherapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C1514461
UMLS CUI [2,2]
C0600139
major surgery within 4 weeks before randomization;
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
Description

5-alpha Reductase Inhibitors | Finasteride | Dutasteride

Data type

boolean

Alias
UMLS CUI [1]
C2936788
UMLS CUI [2]
C0060389
UMLS CUI [3]
C0754659
known or suspected brain metastasis or active leptomeningeal disease;
Description

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected | Leptomeningeal disease | Leptomeningeal disease Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0751297
UMLS CUI [4,1]
C0751297
UMLS CUI [4,2]
C0750491
history of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
Description

Invasive cancer Other | Exception Malignant Neoplasms Treated | Exception Recurrence Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0034897
UMLS CUI [3,3]
C0750558
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Similar models

Eligibility Hormone Sensitive Prostate Cancer NCT02319837

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate Biopsy | Neuroendocrine Differentiation Absent | Signet ring cell Absent | Absence Feature Cells Small
Item
histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
boolean
C0007112 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1709218 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0333727 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C2348519 (UMLS CUI [4,2])
C0007634 (UMLS CUI [4,3])
C0700321 (UMLS CUI [4,4])
Radical prostatectomy Curative intent Prostate carcinoma | Therapeutic radiology procedure Curative intent Prostate carcinoma | Brachytherapy Curative intent Prostate carcinoma
Item
prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
boolean
C0194810 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C0006098 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C0600139 (UMLS CUI [3,3])
PSA Doubling Time
Item
psa doubling time ≤ 9 months;
boolean
C0138741 (UMLS CUI [1,1])
C2986483 (UMLS CUI [1,2])
Prostate specific antigen measurement | Radical prostatectomy Prostate carcinoma
Item
screening psa ≥ 2.0 ng/ml for patients who had radical prostatectomy as primary treatment for prostate cancer or ≥ 5.0 ng/ml and greater than or equal to the nadir +
boolean
C0201544 (UMLS CUI [1])
C0194810 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Therapeutic radiology procedure Prostate carcinoma
Item
2 ng/ml for patients who had radiotherapy as primary treatment for prostate cancer;
boolean
C1522449 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Serum testosterone measurement
Item
serum testosterone ≥ 150 ng/dl (5.2 nmol/l).
boolean
C0428413 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Distant metastasis Radiographic imaging
Item
prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
boolean
C1269798 (UMLS CUI [1,1])
C0457276 (UMLS CUI [1,2])
Prior Hormone Therapy Prostate carcinoma | Exception Neoadjuvant Therapy | Exception Adjuvant therapy
Item
prior hormonal therapy other than neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization;
boolean
C1514460 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
Cytotoxic Chemotherapy Prostate carcinoma | Aminoglutethimide | Ketoconazole | abiraterone acetate | enzalutamide
Item
prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
boolean
C0677881 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0002555 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
C2607886 (UMLS CUI [4])
C3496793 (UMLS CUI [5])
Biological treatment Systemic Prostate carcinoma | Prior Immunotherapy Prostate carcinoma
Item
prior systemic biologic therapy, including immunotherapy, for prostate cancer;
boolean
C1531518 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C1514461 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Major surgery
Item
major surgery within 4 weeks before randomization;
boolean
C0679637 (UMLS CUI [1])
5-alpha Reductase Inhibitors | Finasteride | Dutasteride
Item
treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
boolean
C2936788 (UMLS CUI [1])
C0060389 (UMLS CUI [2])
C0754659 (UMLS CUI [3])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected | Leptomeningeal disease | Leptomeningeal disease Suspected
Item
known or suspected brain metastasis or active leptomeningeal disease;
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0751297 (UMLS CUI [3])
C0751297 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Invasive cancer Other | Exception Malignant Neoplasms Treated | Exception Recurrence Unlikely
Item
history of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
boolean
C0677898 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0034897 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
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