ID

31541

Descrição

Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00439751

Link

https://clinicaltrials.gov/show/NCT00439751

Palavras-chave

Versões (1)
  1. 03/09/2018 03/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00439751

Inglês

Eligibility Prostate Cancer NCT00439751

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males over 18 years of age with histological confirmation of adenocarcinoma of the prostate.
Descrição

Age | Adenocarcinoma of prostate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0007112
2. biochemical progression after radical radiotherapy with a total prostate dose > 52 gy.
Descrição

Therapeutic radiology procedure Radical Prostate Total Dose | Progression Biochemical

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0439807
UMLS CUI [1,3]
C0033572
UMLS CUI [1,4]
C2986497
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0205474
in patients without previous radical prostatectomy, biochemical progression is defined as psa in the range of nadir + 2 ng/ml (phoenix definition) to ≤ 6 ng/ml (this psa must be within 30 days of randomization).
Descrição

Radical prostatectomy Absent | Progression Biochemical | Prostate specific antigen measurement Nadir

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0205474
UMLS CUI [3,1]
C0201544
UMLS CUI [3,2]
C1708760
in patients with previous radical prostatectomy, biochemical progression is defined as a rising psa (at least 2 values) in the range of 0.4 ng/ml to ≤ 3 ng/ml (most recent psa must be within 30 days of randomization).
Descrição

Radical prostatectomy | Progression Biochemical | Raised prostate specific antigen

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0194810
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0205474
UMLS CUI [3]
C0178415
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who are within 4 years of their brachytherapy implantation date.
Descrição

Brachytherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006098
2. patients with medical conditions in which goserelin or bicalutamide is contraindicated in the opinion of the supervising oncologist or urologist.
Descrição

Medical condition Contraindicated Goserelin | Medical condition Contraindicated Bicalutamide

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0120107
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C0285590
3. patients with another active malignancy or malignancy treatment within 5 years (basal or squamous cell skin cancers are not excluded from this trial).
Descrição

Cancer Other | Cancer treatment Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
4. patients with geographic inaccessibility precluding them from necessary follow-up.
Descrição

Geographic Factors Exclude Follow-up

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017444
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C3274571
5. failure to provide written informed consent.
Descrição

Informed Consent failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
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Similar models

Eligibility Prostate Cancer NCT00439751

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Adenocarcinoma of prostate
Item
1. males over 18 years of age with histological confirmation of adenocarcinoma of the prostate.
boolean
C0001779 (UMLS CUI [1])
C0007112 (UMLS CUI [2])
Therapeutic radiology procedure Radical Prostate Total Dose | Progression Biochemical
Item
2. biochemical progression after radical radiotherapy with a total prostate dose > 52 gy.
boolean
C1522449 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0033572 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,4])
C0242656 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
Radical prostatectomy Absent | Progression Biochemical | Prostate specific antigen measurement Nadir
Item
in patients without previous radical prostatectomy, biochemical progression is defined as psa in the range of nadir + 2 ng/ml (phoenix definition) to ≤ 6 ng/ml (this psa must be within 30 days of randomization).
boolean
C0194810 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3,1])
C1708760 (UMLS CUI [3,2])
Radical prostatectomy | Progression Biochemical | Raised prostate specific antigen
Item
in patients with previous radical prostatectomy, biochemical progression is defined as a rising psa (at least 2 values) in the range of 0.4 ng/ml to ≤ 3 ng/ml (most recent psa must be within 30 days of randomization).
boolean
C0194810 (UMLS CUI [1])
C0242656 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
C0178415 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Brachytherapy
Item
1. patients who are within 4 years of their brachytherapy implantation date.
boolean
C0006098 (UMLS CUI [1])
Medical condition Contraindicated Goserelin | Medical condition Contraindicated Bicalutamide
Item
2. patients with medical conditions in which goserelin or bicalutamide is contraindicated in the opinion of the supervising oncologist or urologist.
boolean
C3843040 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0120107 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C0285590 (UMLS CUI [2,3])
Cancer Other | Cancer treatment Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
3. patients with another active malignancy or malignancy treatment within 5 years (basal or squamous cell skin cancers are not excluded from this trial).
boolean
C1707251 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Geographic Factors Exclude Follow-up
Item
4. patients with geographic inaccessibility precluding them from necessary follow-up.
boolean
C0017444 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Informed Consent failed
Item
5. failure to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
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