ID

36858

Description

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

Keywords

Versions (1)
  1. 6/17/19 6/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02159690

English

Eligibility Prostate Cancer NCT02159690

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Adenocarcinoma of prostate

Data type

boolean

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

Prostatectomy Prostate carcinoma Localized

Data type

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
Description

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

Data type

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
Description

Serum testosterone measurement

Data type

boolean

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

Able to swallow Investigational New Drugs Tablets

Data type

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).
Description

Abiraterone acetate on empty stomach

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

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

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

Data type

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
Description

Enzalutamide Previous | Abiraterone acetate Previous

Data type

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:
Description

Systemic therapy Prostate carcinoma

Data type

boolean

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

Hormone Therapy | Leuprolide | Goserelin | Triptorelin | degarelix

Data type

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)
Description

CYP17 Inhibitor | Ketoconazole

Data type

boolean

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

Androgen Antagonists | bicalutamide | nilutamide

Data type

boolean

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

Androgen Antagonists Generation second | enzalutamide | ARN-509

Data type

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)
Description

Immunotherapy | sipuleucel-T | ipilimumab

Data type

boolean

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

Chemotherapy | docetaxel | cabazitaxel

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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]
Description

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

Data type

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)
Description

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

Data type

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)
Description

Abnormal renal function | Serum creatinine raised

Data type

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.
Description

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

Data type

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.
Description

Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
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Similar models

Eligibility Prostate Cancer NCT02159690

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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