ID

18973

Beschreibung

A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00116779

Link

https://clinicaltrials.gov/show/NCT00116779

Stichworte

Versionen (1)
  1. 27.11.16 27.11.16 -
Hochgeladen am

27. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00116779

Englisch

Eligibility Prostate Cancer NCT00116779

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
each patient must meet the following inclusion criteria before entry into the study.
Beschreibung

Inclusion criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. this includes patients with rising psa after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.
Beschreibung

Adenocarcinoma of prostate TNM clinical staging | Indication Hormone Therapy | Hormone Therapy Neoadjuvant | Raised prostate specific antigen | Radical prostatectomy | Therapeutic radiology procedure Curative intent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0279025
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0600558
UMLS CUI [4]
C0178415
UMLS CUI [5]
C0194810
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C1276305
male patient aged 18 years or over.
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
has a baseline testosterone above the lower limit of normal range.
Beschreibung

Testosterone measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0523912
has an ecog (eastern co-operative oncology group) score equal to or less than 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
has a psa value of greater than or equal to 2ng/ml.
Beschreibung

Prostate specific antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any patient meeting one or more of the following exclusion criteria will not be entered into the study.
Beschreibung

Exclusion Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. gnrh agonists, gnrh antagonists, antiandrogens, estrogens). however, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the screening visit.
Beschreibung

Hormone Therapy Prostate carcinoma | Castration | Gonadotropin Releasing Hormone Receptor Agonist | Gonadotropin releasing hormone antagonist | Androgen Antagonists | Estrogens | Hormone Therapy Neoadjuvant | Prostatectomy | Therapeutic radiology procedure Curative intent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0007347
UMLS CUI [3]
C2267073
UMLS CUI [4]
C1268855
UMLS CUI [5]
C0002842
UMLS CUI [6]
C0014939
UMLS CUI [7,1]
C0279025
UMLS CUI [7,2]
C0600558
UMLS CUI [8]
C0033573
UMLS CUI [9,1]
C1522449
UMLS CUI [9,2]
C1276305
currently or recently (within the last 12 weeks preceding the screening visit) under treatment with any other drug modifying testosterone level or function.
Beschreibung

Pharmaceutical Preparation Changing Testosterone level | Pharmaceutical Preparation Changing Testosterone function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0428412
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0039601
UMLS CUI [2,4]
C0031843
is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from screening visit.
Beschreibung

Indication curative treatment | Indication Radical prostatectomy | Indication Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1273390
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0194810
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1522449
has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or quincke's edema.
Beschreibung

Severe asthma | Steroids Oral Asthma control | Inhaled steroids Asthma control | anaphylaxis | Angioedema

Datentyp

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0004096
UMLS CUI [2,4]
C0243148
UMLS CUI [3,1]
C2065041
UMLS CUI [3,2]
C0004096
UMLS CUI [3,3]
C0243148
UMLS CUI [4]
C0002792
UMLS CUI [5]
C0002994
has hypersensitivity towards any component of the investigational products (degarelix or mannitol).
Beschreibung

Hypersensitivity Investigational New Drugs Component | Hypersensitivity degarelix | Mannitol allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1455035
UMLS CUI [3]
C0571922
has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
Beschreibung

Malignant Neoplasms | Prostate carcinoma | Basal cell carcinoma Resected | Squamous cell carcinoma of skin Resected

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0600139
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1521996
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1521996
has elevated serum alt level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the screening visit.
Beschreibung

Alanine aminotransferase increased | SERUM TOTAL BILIRUBIN ELEVATED

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0595866
has known or suspect hepatic disease of any sort. patients with liver disease are not to be enrolled in this study.
Beschreibung

Liver diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.
Beschreibung

LABORATORY ABNORMALITIES Interfere with Study Subject Participation Status | LABORATORY ABNORMALITIES Interfere with research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1853129
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator.
Beschreibung

Disease Clinical Significance Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Disease Clinical Significance Interferes with research results | Condition Interferes with research results | Prostate carcinoma | Substance Use Disorders Excessive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5]
C0600139
UMLS CUI [6,1]
C0038586
UMLS CUI [6,2]
C0442802
has a mental incapacity or language barriers precluding adequate understanding or cooperation.
Beschreibung

Mental handicap Excludes Comprehension | Language Barrier Excludes Comprehension | Mental handicap Excludes Compliance behavior | Language Barrier Excludes Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [2,1]
C0237167
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0162340
UMLS CUI [3,1]
C1306341
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1321605
UMLS CUI [4,1]
C0237167
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C1321605
has received an investigational drug within the last 12 weeks preceding screening visit.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
has previously participated in any degarelix study
Beschreibung

Study Subject Participation Status degarelix

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1455035
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00116779

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Fulfill
Item
each patient must meet the following inclusion criteria before entry into the study.
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent
Item
has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of prostate TNM clinical staging | Indication Hormone Therapy | Hormone Therapy Neoadjuvant | Raised prostate specific antigen | Radical prostatectomy | Therapeutic radiology procedure Curative intent
Item
histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. this includes patients with rising psa after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.
boolean
C0007112 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0178415 (UMLS CUI [4])
C0194810 (UMLS CUI [5])
C1522449 (UMLS CUI [6,1])
C1276305 (UMLS CUI [6,2])
Gender | Age
Item
male patient aged 18 years or over.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Testosterone measurement
Item
has a baseline testosterone above the lower limit of normal range.
boolean
C0523912 (UMLS CUI [1])
ECOG performance status
Item
has an ecog (eastern co-operative oncology group) score equal to or less than 2.
boolean
C1520224 (UMLS CUI [1])
Prostate specific antigen measurement
Item
has a psa value of greater than or equal to 2ng/ml.
boolean
C0201544 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Fulfill
Item
any patient meeting one or more of the following exclusion criteria will not be entered into the study.
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Hormone Therapy Prostate carcinoma | Castration | Gonadotropin Releasing Hormone Receptor Agonist | Gonadotropin releasing hormone antagonist | Androgen Antagonists | Estrogens | Hormone Therapy Neoadjuvant | Prostatectomy | Therapeutic radiology procedure Curative intent
Item
previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. gnrh agonists, gnrh antagonists, antiandrogens, estrogens). however, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the screening visit.
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0007347 (UMLS CUI [2])
C2267073 (UMLS CUI [3])
C1268855 (UMLS CUI [4])
C0002842 (UMLS CUI [5])
C0014939 (UMLS CUI [6])
C0279025 (UMLS CUI [7,1])
C0600558 (UMLS CUI [7,2])
C0033573 (UMLS CUI [8])
C1522449 (UMLS CUI [9,1])
C1276305 (UMLS CUI [9,2])
Pharmaceutical Preparation Changing Testosterone level | Pharmaceutical Preparation Changing Testosterone function
Item
currently or recently (within the last 12 weeks preceding the screening visit) under treatment with any other drug modifying testosterone level or function.
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0428412 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0039601 (UMLS CUI [2,3])
C0031843 (UMLS CUI [2,4])
Indication curative treatment | Indication Radical prostatectomy | Indication Therapeutic radiology procedure
Item
is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from screening visit.
boolean
C3146298 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0194810 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
Severe asthma | Steroids Oral Asthma control | Inhaled steroids Asthma control | anaphylaxis | Angioedema
Item
has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or quincke's edema.
boolean
C0581126 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
C0243148 (UMLS CUI [2,4])
C2065041 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C0243148 (UMLS CUI [3,3])
C0002792 (UMLS CUI [4])
C0002994 (UMLS CUI [5])
Hypersensitivity Investigational New Drugs Component | Hypersensitivity degarelix | Mannitol allergy
Item
has hypersensitivity towards any component of the investigational products (degarelix or mannitol).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1455035 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
Malignant Neoplasms | Prostate carcinoma | Basal cell carcinoma Resected | Squamous cell carcinoma of skin Resected
Item
has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C0600139 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1521996 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1521996 (UMLS CUI [4,2])
Alanine aminotransferase increased | SERUM TOTAL BILIRUBIN ELEVATED
Item
has elevated serum alt level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the screening visit.
boolean
C0151905 (UMLS CUI [1])
C0595866 (UMLS CUI [2])
Liver diseases
Item
has known or suspect hepatic disease of any sort. patients with liver disease are not to be enrolled in this study.
boolean
C0023895 (UMLS CUI [1])
LABORATORY ABNORMALITIES Interfere with Study Subject Participation Status | LABORATORY ABNORMALITIES Interfere with research results
Item
has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.
boolean
C1853129 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1853129 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Disease Clinical Significance Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Disease Clinical Significance Interferes with research results | Condition Interferes with research results | Prostate carcinoma | Substance Use Disorders Excessive
Item
has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator.
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0600139 (UMLS CUI [5])
C0038586 (UMLS CUI [6,1])
C0442802 (UMLS CUI [6,2])
Mental handicap Excludes Comprehension | Language Barrier Excludes Comprehension | Mental handicap Excludes Compliance behavior | Language Barrier Excludes Compliance behavior
Item
has a mental incapacity or language barriers precluding adequate understanding or cooperation.
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0237167 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C1306341 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0237167 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
Investigational New Drugs
Item
has received an investigational drug within the last 12 weeks preceding screening visit.
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status degarelix
Item
has previously participated in any degarelix study
boolean
C2348568 (UMLS CUI [1,1])
C1455035 (UMLS CUI [1,2])
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