ID

12840

Description

Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01819285

Link

https://clinicaltrials.gov/show/NCT01819285

Keywords

Versions (1)
  1. 12/29/15 12/29/15 -
Uploaded on

December 29, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoplasm, Prostate NCT01819285

English

Eligibility Neoplasm, Prostate NCT01819285

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate t0-4 n0-2 m0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy)
Description

histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate t0-4 n0-2 m0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy)

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0231221
all t stages are acceptable (uicc 1982). the stage is determined by rectal palpation.
Description

all t stages are acceptable (uicc 1982). the stage is determined by rectal palpation.

Data type

boolean

Alias
UMLS CUI [1,1]
C0027646
UMLS CUI [1,2]
C0441914
patients with regional lymph node metastases smaller than 5 cm (n0-2), determined either by ct or ultrasonography, preferable with cytologic confirmation.
Description

patients with regional lymph node metastases smaller than 5 cm (n0-2), determined either by ct or ultrasonography, preferable with cytologic confirmation.

Data type

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C0205147
life expectancy of at least six months.
Description

life expectancy of at least six months.

Data type

boolean

Alias
UMLS CUI [1]
C0023671
WHO performance status score 0-1.
Description

WHO performance status score 0-1.

Data type

boolean

Alias
UMLS CUI [1]
C1520224
informed consent. patients must be prepared to undergo an orchiectomy or continuous treatment with a depot lhrh analogue.
Description

informed consent. patients must be prepared to undergo an orchiectomy or continuous treatment with a depot lhrh analogue.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
continuous follow-up until death if possible.
Description

continuous follow-up until death if possible.

Data type

boolean

Alias
UMLS CUI [1,1]
C0814423
UMLS CUI [1,2]
C1522577
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin.
Description

other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin.

Data type

boolean

Alias
UMLS CUI [1]
C0006826
prostate cancer known for longer than one month before entering the study.
Description

prostate cancer known for longer than one month before entering the study.

Data type

boolean

Alias
UMLS CUI [1]
C0600139
pain caused by the prostate cancer or its metastases
Description

pain caused by the prostate cancer or its metastases

Data type

boolean

Alias
UMLS CUI [1]
C0596240
any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) note: tur-p for voiding disturbances is allowed at any time and is not an exclusion criterion.
Description

any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) note: tur-p for voiding disturbances is allowed at any time and is not an exclusion criterion.

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0006826
patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins).
Description

patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins)

Data type

boolean

Alias
UMLS CUI [1]
C0041956
patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, n3-4).
Description

patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, n3-4).

Data type

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C0522499
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0205147
patients with evidence of distant metastases (bone, lung, liver).
Description

patients with evidence of distant metastases (bone, lung, liver).

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0443203
age over 80 years. performance status who score 2, 3 and 4 (any reason).
Description

age over 80 years. performance status who score 2, 3 and 4 (any reason).

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
patient who refuses orchiectomy or longterm subcutaneous implants of lhrh analogue in two monthly intervals.
Description

patient who refuses orchiectomy or longterm subcutaneous implants of lhrh analogue in two monthly intervals.

Data type

boolean

Alias
UMLS CUI [1]
C0029189
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C0443315
UMLS CUI [2,3]
C2267072
expected difficulties with follow-up for any reason.
Description

expected difficulties with follow-up for any reason.

Data type

boolean

Alias
UMLS CUI [1]
C1522577
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Similar models

Eligibility Neoplasm, Prostate NCT01819285

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
prostate carcinoma
Item
histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate t0-4 n0-2 m0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy)
boolean
C0600139 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
tumor staging
Item
all t stages are acceptable (uicc 1982). the stage is determined by rectal palpation.
boolean
C0027646 (UMLS CUI [1,1])
C0441914 (UMLS CUI [1,2])
lymph node metastases
Item
patients with regional lymph node metastases smaller than 5 cm (n0-2), determined either by ct or ultrasonography, preferable with cytologic confirmation.
boolean
C0686619 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
life expectancy
Item
life expectancy of at least six months.
boolean
C0023671 (UMLS CUI [1])
performance status
Item
WHO performance status score 0-1.
boolean
C1520224 (UMLS CUI [1])
informed consent
Item
informed consent. patients must be prepared to undergo an orchiectomy or continuous treatment with a depot lhrh analogue.
boolean
C0021430 (UMLS CUI [1])
follow-up
Item
continuous follow-up until death if possible.
boolean
C0814423 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
other malignancies
Item
other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
prostate cancer
Item
prostate cancer known for longer than one month before entering the study.
boolean
C0600139 (UMLS CUI [1])
cancer pain
Item
pain caused by the prostate cancer or its metastases
boolean
C0596240 (UMLS CUI [1])
previous cancer treatment
Item
any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) note: tur-p for voiding disturbances is allowed at any time and is not an exclusion criterion.
boolean
C0087111 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
locally advanced disease
Item
patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins).
boolean
C0041956 (UMLS CUI [1])
lymph node metastasis
Item
patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, n3-4).
boolean
C0686619 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C0686619 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
distant metastases
Item
patients with evidence of distant metastases (bone, lung, liver).
boolean
C0027627 (UMLS CUI [1,1])
C0443203 (UMLS CUI [1,2])
age and performance status
Item
age over 80 years. performance status who score 2, 3 and 4 (any reason).
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
cancer treatment
Item
patient who refuses orchiectomy or longterm subcutaneous implants of lhrh analogue in two monthly intervals.
boolean
C0029189 (UMLS CUI [1])
C0021102 (UMLS CUI [2,1])
C0443315 (UMLS CUI [2,2])
C2267072 (UMLS CUI [2,3])
difficulties with follow-up
Item
expected difficulties with follow-up for any reason.
boolean
C1522577 (UMLS CUI [1])
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