ID

36858

Descripción

A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT02159690

Link

https://clinicaltrials.gov/show/NCT02159690

Palabras clave

Versiones (1)
  1. 17/6/19 17/6/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

17 de junio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Prostate Cancer NCT02159690

Inglés

Eligibility Prostate Cancer NCT02159690

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. willing and able to provide written informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. age ≥ 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. eastern cooperative group (ecog) performance status ≤2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
4. documented histologically confirmed adenocarcinoma of the prostate
Descripción

Adenocarcinoma of prostate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007112
5. willing to undergo prostatectomy as primary treatment for localized prostate cancer
Descripción

Prostatectomy Prostate carcinoma Localized

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0392752
6. high risk prostate cancer (per nccn criteria): gleason score 8-10 or t3a or psa > 20 ng/ml -or- very-high risk prostate cancer (per nccn criteria): t3b -t4
Descripción

High risk Prostate carcinoma | Gleason score | TNM clinical staging | PSA measurement | High risk Very Prostate carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C3203027
UMLS CUI [3]
C3258246
UMLS CUI [4]
C0201544
UMLS CUI [5,1]
C4319571
UMLS CUI [5,2]
C0442824
UMLS CUI [5,3]
C0600139
7. serum testosterone ≥150 ng/dl
Descripción

Serum testosterone measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428413
8. able to swallow the study drugs whole as tablets
Descripción

Able to swallow Investigational New Drugs Tablets

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0039225
9. willing to take abiraterone acetate on an empty stomach (no food should be consumed at least two hours before and for one hour after dosing).
Descripción

Abiraterone acetate on empty stomach

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2607886
UMLS CUI [1,2]
C4274031
10. willing to use a condom if having sex with a pregnant woman, or use a condom and another effective method of birth control if having sex with a woman of child-bearing potential. these measures are required during and for one week after treatment with abiraterone.
Descripción

Condom use Coitus Pregnant Women | Condom use Coitus Childbearing Potential | Contraceptive methods Coitus Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679782
UMLS CUI [1,2]
C0009253
UMLS CUI [1,3]
C0033011
UMLS CUI [2,1]
C0679782
UMLS CUI [2,2]
C0009253
UMLS CUI [2,3]
C3831118
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0009253
UMLS CUI [3,3]
C3831118
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
Descripción

Local Therapy Prostate carcinoma | Radical prostatectomy | Therapeutic radiology procedure | Brachytherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0194810
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0006098
2. prior use of enzalutamide or abiraterone acetate
Descripción

Enzalutamide Previous | Abiraterone acetate Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3496793
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2607886
UMLS CUI [2,2]
C0205156
3. prior or ongoing systemic therapy for prostate cancer including, but not limited to:
Descripción

Systemic therapy Prostate carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0600139
1. hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
Descripción

Hormone Therapy | Leuprolide | Goserelin | Triptorelin | degarelix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0085272
UMLS CUI [3]
C0120107
UMLS CUI [4]
C0077275
UMLS CUI [5]
C1455035
2. cyp-17 inhibitors (e.g. ketoconazole)
Descripción

CYP17 Inhibitor | Ketoconazole

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3160096
UMLS CUI [2]
C0022625
3. antiandrogens (e.g. bicalutamide, nilutamide)
Descripción

Androgen Antagonists | bicalutamide | nilutamide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002842
UMLS CUI [2]
C0285590
UMLS CUI [3]
C0068771
4. second generation antiandrogens (e.g. enzalutamide, arn-509)
Descripción

Androgen Antagonists Generation second | enzalutamide | ARN-509

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205436
UMLS CUI [2]
C3496793
UMLS CUI [3]
C2985183
5. immunotherapy (e.g. sipuleucel-t, ipilimumab)
Descripción

Immunotherapy | sipuleucel-T | ipilimumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C1706668
UMLS CUI [3]
C1367202
6. chemotherapy (e.g. docetaxel, cabazitaxel)
Descripción

Chemotherapy | docetaxel | cabazitaxel

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0246415
UMLS CUI [3]
C2830183
4. evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
Descripción

Medical condition Interferes with Patient safety | Medical condition Interferes with Informed Consent | Mental condition Interferes with Patient safety | Mental condition Interferes with Informed Consent | Condition Interferes with Patient safety | Condition Interferes with Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0021430
5. any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
Descripción

Psychological Factor Interferes with Protocol Compliance | Psychological Factor Interferes with Follow-up | Factor familial Interferes with Protocol Compliance | Factor familial Interferes with Follow-up | Sociological Factor Interferes with Protocol Compliance | Sociological Factor Interferes with Follow-up | Geographic Factor Interferes with Protocol Compliance | Geographic Factor Interferes with Follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0033898
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0033898
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0241888
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C1521761
UMLS CUI [4,2]
C0241888
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C3274571
UMLS CUI [5,1]
C3850138
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C3850138
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C3274571
UMLS CUI [7,1]
C0017444
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0017444
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C3274571
6. abnormal bone marrow function [absolute neutrophil count (anc)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dl]
Descripción

Bone Marrow function Abnormal | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205161
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
7. abnormal liver function (bilirubin, ast, alt ≥ 3 x upper limit of normal)
Descripción

Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
8. abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
Descripción

Abnormal renal function | Serum creatinine raised

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0700225
9. abnormal cardiac function as manifested by nyha (new york heart association) class iii or iv heart failure or history of a prior myocardial infarction (mi) within the last five years prior to enrollment in the study.
Descripción

Cardiac function test abnormal | Heart failure New York Heart Association Classification | Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438177
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0027051
10. history of prior cardiac arrhythmia.
Descripción

Cardiac Arrhythmia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003811
Volver a la parte superior de la página

Similar models

Eligibility Prostate Cancer NCT02159690

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. eastern cooperative group (ecog) performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
4. documented histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Prostatectomy Prostate carcinoma Localized
Item
5. willing to undergo prostatectomy as primary treatment for localized prostate cancer
boolean
C0033573 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0392752 (UMLS CUI [1,3])
High risk Prostate carcinoma | Gleason score | TNM clinical staging | PSA measurement | High risk Very Prostate carcinoma
Item
6. high risk prostate cancer (per nccn criteria): gleason score 8-10 or t3a or psa > 20 ng/ml -or- very-high risk prostate cancer (per nccn criteria): t3b -t4
boolean
C4319571 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C3203027 (UMLS CUI [2])
C3258246 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
C4319571 (UMLS CUI [5,1])
C0442824 (UMLS CUI [5,2])
C0600139 (UMLS CUI [5,3])
Serum testosterone measurement
Item
7. serum testosterone ≥150 ng/dl
boolean
C0428413 (UMLS CUI [1])
Able to swallow Investigational New Drugs Tablets
Item
8. able to swallow the study drugs whole as tablets
boolean
C2712086 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Abiraterone acetate on empty stomach
Item
9. willing to take abiraterone acetate on an empty stomach (no food should be consumed at least two hours before and for one hour after dosing).
boolean
C2607886 (UMLS CUI [1,1])
C4274031 (UMLS CUI [1,2])
Condom use Coitus Pregnant Women | Condom use Coitus Childbearing Potential | Contraceptive methods Coitus Childbearing Potential
Item
10. willing to use a condom if having sex with a pregnant woman, or use a condom and another effective method of birth control if having sex with a woman of child-bearing potential. these measures are required during and for one week after treatment with abiraterone.
boolean
C0679782 (UMLS CUI [1,1])
C0009253 (UMLS CUI [1,2])
C0033011 (UMLS CUI [1,3])
C0679782 (UMLS CUI [2,1])
C0009253 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [3,1])
C0009253 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Local Therapy Prostate carcinoma | Radical prostatectomy | Therapeutic radiology procedure | Brachytherapy
Item
1. prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
boolean
C1517925 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0194810 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0006098 (UMLS CUI [4])
Enzalutamide Previous | Abiraterone acetate Previous
Item
2. prior use of enzalutamide or abiraterone acetate
boolean
C3496793 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2607886 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Systemic therapy Prostate carcinoma
Item
3. prior or ongoing systemic therapy for prostate cancer including, but not limited to:
boolean
C1515119 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Hormone Therapy | Leuprolide | Goserelin | Triptorelin | degarelix
Item
1. hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
boolean
C0279025 (UMLS CUI [1])
C0085272 (UMLS CUI [2])
C0120107 (UMLS CUI [3])
C0077275 (UMLS CUI [4])
C1455035 (UMLS CUI [5])
CYP17 Inhibitor | Ketoconazole
Item
2. cyp-17 inhibitors (e.g. ketoconazole)
boolean
C3160096 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
Androgen Antagonists | bicalutamide | nilutamide
Item
3. antiandrogens (e.g. bicalutamide, nilutamide)
boolean
C0002842 (UMLS CUI [1])
C0285590 (UMLS CUI [2])
C0068771 (UMLS CUI [3])
Androgen Antagonists Generation second | enzalutamide | ARN-509
Item
4. second generation antiandrogens (e.g. enzalutamide, arn-509)
boolean
C0002842 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C3496793 (UMLS CUI [2])
C2985183 (UMLS CUI [3])
Immunotherapy | sipuleucel-T | ipilimumab
Item
5. immunotherapy (e.g. sipuleucel-t, ipilimumab)
boolean
C0021083 (UMLS CUI [1])
C1706668 (UMLS CUI [2])
C1367202 (UMLS CUI [3])
Chemotherapy | docetaxel | cabazitaxel
Item
6. chemotherapy (e.g. docetaxel, cabazitaxel)
boolean
C0392920 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
C2830183 (UMLS CUI [3])
Medical condition Interferes with Patient safety | Medical condition Interferes with Informed Consent | Mental condition Interferes with Patient safety | Mental condition Interferes with Informed Consent | Condition Interferes with Patient safety | Condition Interferes with Informed Consent
Item
4. evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
Psychological Factor Interferes with Protocol Compliance | Psychological Factor Interferes with Follow-up | Factor familial Interferes with Protocol Compliance | Factor familial Interferes with Follow-up | Sociological Factor Interferes with Protocol Compliance | Sociological Factor Interferes with Follow-up | Geographic Factor Interferes with Protocol Compliance | Geographic Factor Interferes with Follow-up
Item
5. any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
boolean
C0033898 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0033898 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C1521761 (UMLS CUI [4,1])
C0241888 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
C3850138 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C3850138 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0017444 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C3274571 (UMLS CUI [8,3])
Bone Marrow function Abnormal | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
6. abnormal bone marrow function [absolute neutrophil count (anc)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dl]
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
7. abnormal liver function (bilirubin, ast, alt ≥ 3 x upper limit of normal)
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
Abnormal renal function | Serum creatinine raised
Item
8. abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
boolean
C0151746 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Cardiac function test abnormal | Heart failure New York Heart Association Classification | Myocardial Infarction
Item
9. abnormal cardiac function as manifested by nyha (new york heart association) class iii or iv heart failure or history of a prior myocardial infarction (mi) within the last five years prior to enrollment in the study.
boolean
C0438177 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
Cardiac Arrhythmia
Item
10. history of prior cardiac arrhythmia.
boolean
C0003811 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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