ID

36857

Beschrijving

Investigating the Effects of AZD2014 Therapy Given Prior to Radical Prostatectomy in Men With High Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02064608

Link

https://clinicaltrials.gov/show/NCT02064608

Trefwoorden

Versies (1)
  1. 17-06-19 17-06-19 -
Houder van rechten

See clinicaltrials.gov

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17 juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02064608

Engels

Eligibility Prostate Cancer NCT02064608

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men aged 18 years old or older
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
ecog performance status of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
clinical diagnosis of intermediate (one or more of stage t2, or psa >10ng/ml, or gleason score of at least 7) or high risk prostate cancer (one or more of stage t2c, or psa >20ng/ml, or gleason score of at least 8)
Beschrijving

Intermediate Risk Prostate carcinoma TNM clinical staging | Prostate specific antigen measurement | Gleason score | High risk Prostate carcinoma TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C3640764
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0201544
UMLS CUI [3]
C3203027
UMLS CUI [4,1]
C4319571
UMLS CUI [4,2]
C0600139
UMLS CUI [4,3]
C3258246
patient suitable for radical prostatectomy, following discussion at specialist mdt and subsequent review by surgical team
Beschrijving

Patient Suitable Radical prostatectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0194810
willing to use barrier contraceptive method, e.g. condom & spermicide
Beschrijving

Barrier Contraception Willing | Condoms, Male | Spermatocidal Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004764
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C0009653
UMLS CUI [3]
C0037862
adequate bone marrow reserve or organ function (as specified in the study protocol)
Beschrijving

Bone Marrow Mature Neutrophils Present | Organ function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [2]
C0678852
normal chest radiograph and oxygen saturations, or normal ct thorax
Beschrijving

Chest radiography Normal | Oxygen saturation within reference range | CT thorax normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0853673
UMLS CUI [3]
C1141870
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication to azd2014 (as specified in the study protocol)
Beschrijving

Medical contraindication AZD2014

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2981846
patients who have experienced any of the following procedures in the past 12 months: coronary artery bypass graft; angioplasty; vascular stent; myocardial infarction; angina pectoris; congestive heart failure (new york heart association grade of 2 or above); ventricular arrhythmias requiring continuous therapy; supraventricular arrhythmias including atrial fibrillation, which are uncontrolled; haemorrhagic or thrombotic stroke including transient ischaemic attacks or any other cns bleeding.
Beschrijving

Coronary Artery Bypass Surgery | Angioplasty | Vascular stent | Myocardial Infarction | Angina Pectoris | Congestive heart failure New York Heart Association Classification | Ventricular arrhythmia Treatment required for | Supraventricular arrhythmia Uncontrolled | ATRIAL FIBRILLATION UNCONTROLLED | Brain hemorrhage | Thrombotic stroke | Transient Ischemic Attack | Central nervous system haemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C0162577
UMLS CUI [3]
C0183521
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002962
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C1275491
UMLS CUI [7,1]
C0085612
UMLS CUI [7,2]
C0332121
UMLS CUI [8,1]
C0428974
UMLS CUI [8,2]
C0205318
UMLS CUI [9]
C0741284
UMLS CUI [10]
C0553692
UMLS CUI [11]
C0242129
UMLS CUI [12]
C0007787
UMLS CUI [13]
C3267019
previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 28 days of starting study treatment.
Beschrijving

Chemotherapy | Biological treatment | Therapeutic radiology procedure | Androgens | Thalidomide | Immunotherapy | Antineoplastic Agents | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0002844
UMLS CUI [5]
C0039736
UMLS CUI [6]
C0021083
UMLS CUI [7]
C0003392
UMLS CUI [8]
C0013230
major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study
Beschrijving

Major surgery | Exception Vascular Access Device Placement | Minor Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1519955
UMLS CUI [3]
C0038904
potent or moderate inhibitors and inducers of cyp2c8 if taken within the stated wash-out period: gemfibrozil, trimethoprim, glitazones, montelukast, deferasirox and quercetin (1-week minimum wash out period)
Beschrijving

CYP2C8 Inhibitors Strong | CYP2C8 Inhibitors Moderate | CYP2C8 Inducers Strong | CYP2C8 Inducers Moderate | Gemfibrozil | Trimethoprim | Thiazolidinediones | montelukast | deferasirox | Quercetin

Datatype

boolean

Alias
UMLS CUI [1,1]
C3850061
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850061
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C3850048
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C3850048
UMLS CUI [4,2]
C0205081
UMLS CUI [5]
C0017245
UMLS CUI [6]
C0041041
UMLS CUI [7]
C1257987
UMLS CUI [8]
C0298130
UMLS CUI [9]
C1619629
UMLS CUI [10]
C0034392
any haematopoietic growth factors, e.g. g-csf, gm-csf, within 4 weeks prior to receiving study drug
Beschrijving

Hematopoietic Cell Growth Factors | G-CSF | GM-CSF

Datatype

boolean

Alias
UMLS CUI [1]
C0079490
UMLS CUI [2]
C0079459
UMLS CUI [3]
C0079460
as judged by the investigator, any evidence of severe or uncontrolled systemic disease (as specified in the study protocol)
Beschrijving

Systemic disease Severe | Systemic disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
abnormal echo or muga at baseline
Beschrijving

Echocardiogram abnormal | MUGA scan abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0476369
UMLS CUI [2]
C0853480
mean resting qtc of 470msec or above (as per local reading)
Beschrijving

Prolonged QTc interval resting mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C1560305
UMLS CUI [1,2]
C0035253
UMLS CUI [1,3]
C0444504
concomitant medications known to prolong qt interval, or with factors that increase the risk of qtc prolongation, or risk of arrythmic events (examples specified in study protocol). history of torsades de pointes.
Beschrijving

Pharmaceutical Preparations Causing Prolonged QT interval | Factor At risk Prolonged QT interval | Pharmaceutical Preparations At risk Cardiac Arrhythmia | Torsades de Pointes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0151878
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0003811
UMLS CUI [4]
C0040479
patients with diabetes type i or uncontrolled type ii as judged by the investigator
Beschrijving

Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0743118
judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
Beschrijving

Study Subject Participation Status Inappropriate | Protocol Compliance Unlikely

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0750558
unable to provide informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Prostate Cancer NCT02064608

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men aged 18 years old or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Intermediate Risk Prostate carcinoma TNM clinical staging | Prostate specific antigen measurement | Gleason score | High risk Prostate carcinoma TNM clinical staging
Item
clinical diagnosis of intermediate (one or more of stage t2, or psa >10ng/ml, or gleason score of at least 7) or high risk prostate cancer (one or more of stage t2c, or psa >20ng/ml, or gleason score of at least 8)
boolean
C3640764 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0201544 (UMLS CUI [2])
C3203027 (UMLS CUI [3])
C4319571 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
Patient Suitable Radical prostatectomy
Item
patient suitable for radical prostatectomy, following discussion at specialist mdt and subsequent review by surgical team
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
Barrier Contraception Willing | Condoms, Male | Spermatocidal Agents
Item
willing to use barrier contraceptive method, e.g. condom & spermicide
boolean
C0004764 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
C0037862 (UMLS CUI [3])
Bone Marrow Mature Neutrophils Present | Organ function
Item
adequate bone marrow reserve or organ function (as specified in the study protocol)
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Chest radiography Normal | Oxygen saturation within reference range | CT thorax normal
Item
normal chest radiograph and oxygen saturations, or normal ct thorax
boolean
C0039985 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0853673 (UMLS CUI [2])
C1141870 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication AZD2014
Item
contraindication to azd2014 (as specified in the study protocol)
boolean
C1301624 (UMLS CUI [1,1])
C2981846 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery | Angioplasty | Vascular stent | Myocardial Infarction | Angina Pectoris | Congestive heart failure New York Heart Association Classification | Ventricular arrhythmia Treatment required for | Supraventricular arrhythmia Uncontrolled | ATRIAL FIBRILLATION UNCONTROLLED | Brain hemorrhage | Thrombotic stroke | Transient Ischemic Attack | Central nervous system haemorrhage
Item
patients who have experienced any of the following procedures in the past 12 months: coronary artery bypass graft; angioplasty; vascular stent; myocardial infarction; angina pectoris; congestive heart failure (new york heart association grade of 2 or above); ventricular arrhythmias requiring continuous therapy; supraventricular arrhythmias including atrial fibrillation, which are uncontrolled; haemorrhagic or thrombotic stroke including transient ischaemic attacks or any other cns bleeding.
boolean
C0010055 (UMLS CUI [1])
C0162577 (UMLS CUI [2])
C0183521 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C0085612 (UMLS CUI [7,1])
C0332121 (UMLS CUI [7,2])
C0428974 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C0741284 (UMLS CUI [9])
C0553692 (UMLS CUI [10])
C0242129 (UMLS CUI [11])
C0007787 (UMLS CUI [12])
C3267019 (UMLS CUI [13])
Chemotherapy | Biological treatment | Therapeutic radiology procedure | Androgens | Thalidomide | Immunotherapy | Antineoplastic Agents | Investigational New Drugs
Item
previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 28 days of starting study treatment.
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0002844 (UMLS CUI [4])
C0039736 (UMLS CUI [5])
C0021083 (UMLS CUI [6])
C0003392 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Major surgery | Exception Vascular Access Device Placement | Minor Surgical Procedures
Item
major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1519955 (UMLS CUI [2,2])
C0038904 (UMLS CUI [3])
CYP2C8 Inhibitors Strong | CYP2C8 Inhibitors Moderate | CYP2C8 Inducers Strong | CYP2C8 Inducers Moderate | Gemfibrozil | Trimethoprim | Thiazolidinediones | montelukast | deferasirox | Quercetin
Item
potent or moderate inhibitors and inducers of cyp2c8 if taken within the stated wash-out period: gemfibrozil, trimethoprim, glitazones, montelukast, deferasirox and quercetin (1-week minimum wash out period)
boolean
C3850061 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850061 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3850048 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3850048 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C0017245 (UMLS CUI [5])
C0041041 (UMLS CUI [6])
C1257987 (UMLS CUI [7])
C0298130 (UMLS CUI [8])
C1619629 (UMLS CUI [9])
C0034392 (UMLS CUI [10])
Hematopoietic Cell Growth Factors | G-CSF | GM-CSF
Item
any haematopoietic growth factors, e.g. g-csf, gm-csf, within 4 weeks prior to receiving study drug
boolean
C0079490 (UMLS CUI [1])
C0079459 (UMLS CUI [2])
C0079460 (UMLS CUI [3])
Systemic disease Severe | Systemic disease Uncontrolled
Item
as judged by the investigator, any evidence of severe or uncontrolled systemic disease (as specified in the study protocol)
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Echocardiogram abnormal | MUGA scan abnormal
Item
abnormal echo or muga at baseline
boolean
C0476369 (UMLS CUI [1])
C0853480 (UMLS CUI [2])
Prolonged QTc interval resting mean
Item
mean resting qtc of 470msec or above (as per local reading)
boolean
C1560305 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
Pharmaceutical Preparations Causing Prolonged QT interval | Factor At risk Prolonged QT interval | Pharmaceutical Preparations At risk Cardiac Arrhythmia | Torsades de Pointes
Item
concomitant medications known to prolong qt interval, or with factors that increase the risk of qtc prolongation, or risk of arrythmic events (examples specified in study protocol). history of torsades de pointes.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0151878 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0003811 (UMLS CUI [3,3])
C0040479 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED
Item
patients with diabetes type i or uncontrolled type ii as judged by the investigator
boolean
C0011854 (UMLS CUI [1])
C0743118 (UMLS CUI [2])
Study Subject Participation Status Inappropriate | Protocol Compliance Unlikely
Item
judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
Informed Consent Unable
Item
unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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