ID

19068

Beschrijving

Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00174863

Link

https://clinicaltrials.gov/show/NCT00174863

Trefwoorden

Versies (1)
  1. 02-12-16 02-12-16 -
Geüploaded op

2 december 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasm NCT00174863

Engels

Eligibility Prostatic Neoplasm NCT00174863

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
prior confirmed histological diagnosis of prostatic carcinoma.
Beschrijving

Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
rising psa while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; psa must be at least 4ng/ml at the time of study entry.
Beschrijving

Raised prostate specific antigen Quantity | Hormone Therapy | Male Castration | Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0007347
UMLS CUI [4]
C0201544
no distant metastases as evidenced by bone scan (+ or - centered x-ray or mri), and spiral thoracoabdominopelvic ct scan.
Beschrijving

TNM clinical staging - distant metastases Evidence of | Scan of bone | X-ray | Magnetic Resonance Imaging | Tomography, Spiral Computed

Datatype

boolean

Alias
UMLS CUI [1,1]
C3258247
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0203668
UMLS CUI [3]
C0034571
UMLS CUI [4]
C0024485
UMLS CUI [5]
C0860888
effective castration throughout the study. any prior anti-androgen therapy should be stopped with documented continued elevation of psa 4 weeks after the cessation of flutamide (6 weeks for bicalutamide).
Beschrijving

Male Castration | Antiandrogen therapy To be stopped | Raised prostate specific antigen | Flutamide | bicalutamide

Datatype

boolean

Alias
UMLS CUI [1]
C0007347
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C1272691
UMLS CUI [3]
C0178415
UMLS CUI [4]
C0016384
UMLS CUI [5]
C0285590
serum testosterone levels < 50ng/dl at the time of progression and throughout the study.
Beschrijving

Serum testosterone measurement | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1]
C0428413
UMLS CUI [2]
C0242656
age > or = to 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
extensive metabolizer by cyp2d6 genotyping.
Beschrijving

CYP2D6 extensive metaboliser status

Datatype

boolean

Alias
UMLS CUI [1]
C3888997
karnofsky performance status > or = to 70% and life expectancy > 6 months.
Beschrijving

Karnofsky Performance Status | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0023671
adequate hematological, renal and liver function.
Beschrijving

Hematologic function | Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
signed written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
poor metabolizers by cyp2d6 genotyping.
Beschrijving

CYP2D6 poor metaboliser status

Datatype

boolean

Alias
UMLS CUI [1]
C3888904
prior palliative radiotherapy or any prior chemotherapy or experimental therapy.
Beschrijving

Palliative radiotherapy | Chemotherapy | Therapies, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C0475092
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0949266
more than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry.
Beschrijving

Estrogen cancer treatment Quantity | Estramustine cancer treatment Quantity | Therapeutic procedure Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0014939
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0014921
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1444662
concomitant administration of biphosphonate or chronic corticosteroids.
Beschrijving

Diphosphonates | Adrenal Cortex Hormones chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205191
presence of progressive symptoms not adequately controlled with non opioid medications
Beschrijving

PROGRESSIVE SYMPTOMS Control Inadequate Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1,1]
C0240807
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C0205412
UMLS CUI [1,4]
C0013227
concomitant use of medications known to be cytochrome p450 2d6 inhibitors as listed in protocol appendice
Beschrijving

Cytochrome P450 2D6 Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C2962190
previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer
Beschrijving

Malignant Neoplasms | Interval Disease Free of | Skin carcinoma Curative treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1272706
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C1273390
other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.
Beschrijving

Illness Serious Preventing Therapeutic procedure | Medical condition Preventing Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0087111
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Similar models

Eligibility Prostatic Neoplasm NCT00174863

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
prior confirmed histological diagnosis of prostatic carcinoma.
boolean
C0600139 (UMLS CUI [1])
Raised prostate specific antigen Quantity | Hormone Therapy | Male Castration | Prostate specific antigen measurement
Item
rising psa while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; psa must be at least 4ng/ml at the time of study entry.
boolean
C0178415 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C0007347 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
TNM clinical staging - distant metastases Evidence of | Scan of bone | X-ray | Magnetic Resonance Imaging | Tomography, Spiral Computed
Item
no distant metastases as evidenced by bone scan (+ or - centered x-ray or mri), and spiral thoracoabdominopelvic ct scan.
boolean
C3258247 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0203668 (UMLS CUI [2])
C0034571 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0860888 (UMLS CUI [5])
Male Castration | Antiandrogen therapy To be stopped | Raised prostate specific antigen | Flutamide | bicalutamide
Item
effective castration throughout the study. any prior anti-androgen therapy should be stopped with documented continued elevation of psa 4 weeks after the cessation of flutamide (6 weeks for bicalutamide).
boolean
C0007347 (UMLS CUI [1])
C0279492 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0178415 (UMLS CUI [3])
C0016384 (UMLS CUI [4])
C0285590 (UMLS CUI [5])
Serum testosterone measurement | Disease Progression
Item
serum testosterone levels < 50ng/dl at the time of progression and throughout the study.
boolean
C0428413 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Age
Item
age > or = to 18 years.
boolean
C0001779 (UMLS CUI [1])
CYP2D6 extensive metaboliser status
Item
extensive metabolizer by cyp2d6 genotyping.
boolean
C3888997 (UMLS CUI [1])
Karnofsky Performance Status | Life Expectancy
Item
karnofsky performance status > or = to 70% and life expectancy > 6 months.
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hematologic function | Renal function | Liver function
Item
adequate hematological, renal and liver function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CYP2D6 poor metaboliser status
Item
poor metabolizers by cyp2d6 genotyping.
boolean
C3888904 (UMLS CUI [1])
Palliative radiotherapy | Chemotherapy | Therapies, Investigational
Item
prior palliative radiotherapy or any prior chemotherapy or experimental therapy.
boolean
C0475092 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Estrogen cancer treatment Quantity | Estramustine cancer treatment Quantity | Therapeutic procedure Discontinued
Item
more than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry.
boolean
C0014939 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0014921 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Diphosphonates | Adrenal Cortex Hormones chronic
Item
concomitant administration of biphosphonate or chronic corticosteroids.
boolean
C0012544 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
PROGRESSIVE SYMPTOMS Control Inadequate Pharmaceutical Preparations
Item
presence of progressive symptoms not adequately controlled with non opioid medications
boolean
C0240807 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Cytochrome P450 2D6 Inhibitors
Item
concomitant use of medications known to be cytochrome p450 2d6 inhibitors as listed in protocol appendice
boolean
C2962190 (UMLS CUI [1])
Malignant Neoplasms | Interval Disease Free of | Skin carcinoma Curative treatment
Item
previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer
boolean
C0006826 (UMLS CUI [1])
C1272706 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0699893 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
Illness Serious Preventing Therapeutic procedure | Medical condition Preventing Therapeutic procedure
Item
other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
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