ID

36098

Beschrijving

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

Trefwoorden

Versies (1)
  1. 15-04-19 15-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

15 april 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hormone Sensitive Prostate Cancer NCT02319837

Engels

Eligibility Hormone Sensitive Prostate Cancer NCT02319837

1 Formulieren  
Inclusion Criteria
Beschrijving

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;
Beschrijving

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

Datatype

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;
Beschrijving

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

Datatype

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;
Beschrijving

PSA Doubling Time

Datatype

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 +
Beschrijving

Prostate specific antigen measurement | Radical prostatectomy Prostate carcinoma

Datatype

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;
Beschrijving

Therapeutic radiology procedure Prostate carcinoma

Datatype

boolean

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

Serum testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0428413
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Distant metastasis Radiographic imaging

Datatype

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;
Beschrijving

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

Datatype

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;
Beschrijving

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

Datatype

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;
Beschrijving

Biological treatment Systemic Prostate carcinoma | Prior Immunotherapy Prostate carcinoma

Datatype

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;
Beschrijving

Major surgery

Datatype

boolean

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

5-alpha Reductase Inhibitors | Finasteride | Dutasteride

Datatype

boolean

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

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

Datatype

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
Beschrijving

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

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility Hormone Sensitive Prostate Cancer NCT02319837

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial