ID

31541

Description

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

Keywords

Versions (1)
  1. 9/3/18 9/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 3, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostate Cancer NCT00439751

English

Eligibility Prostate Cancer NCT00439751

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Adenocarcinoma of prostate

Data type

boolean

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

Therapeutic radiology procedure Radical Prostate Total Dose | Progression Biochemical

Data type

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).
Description

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

Data type

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).
Description

Radical prostatectomy | Progression Biochemical | Raised prostate specific antigen

Data type

boolean

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

Exclusion Criteria

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

Brachytherapy

Data type

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.
Description

Medical condition Contraindicated Goserelin | Medical condition Contraindicated Bicalutamide

Data type

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).
Description

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

Data type

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.
Description

Geographic Factors Exclude Follow-up

Data type

boolean

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

Informed Consent failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
Back to the top of the page

Similar models

Eligibility Prostate Cancer NCT00439751

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial