ID

22585

Description

A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD; ODM derived from: https://clinicaltrials.gov/show/NCT00378690

Link

https://clinicaltrials.gov/show/NCT00378690

Keywords

Versions (1)
  1. 6/8/17 6/8/17 -
Uploaded on

June 8, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00004016 NCT00378690

English

Eligibility Prostate Cancer NCT00378690

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
at study entry (visit 1):
Description

Clinical Trial Start time

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1301880
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
male subjects aged >=18 and <80 years old
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
locally advanced (stage t3 or t4) prostate cancer or relapsing prostate cancer following radical prostatectomy or,relapsing prostate cancer following radiotherapy
Description

Prostate carcinoma Advanced Local TNM clinical staging | Prostate cancer recurrent Post Radical prostatectomy | Prostate cancer recurrent Post Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278838
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0194810
UMLS CUI [3,1]
C0278838
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1522449
gleason score of >=6
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
ecog performance status of 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy at least 5 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
at randomization (visit 4):
Description

Randomization Timepoint

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C2348792
two successive decreasing serum psa levels <=1 ng/ml
Description

Prostatic specific antigen decreased Levels Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0178414
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
at study entry (visit 1):
Description

Clinical Trial Start time

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1301880
any suspected second primary tumors
Description

Second Primary Cancers Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C0750491
evidence of metastatic disease
Description

Neoplasm Metastasis Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
other malignancy within the last 5 years except
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
acute spinal cord compression, uni- or bilateral ureteric obstruction
Description

Compression of spinal cord | Ureteral obstruction Unilateral | Ureteral obstruction Bilateral

Data type

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2,1]
C0041956
UMLS CUI [2,2]
C0205092
UMLS CUI [3,1]
C0041956
UMLS CUI [3,2]
C0238767
any concurrent biological response modifier therapy
Description

Biological Response Modifier Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0005527
concurrent chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy
Description

Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1522673
less than 6 months since prior 5-alpha reductase inhibitor treatment
Description

5-alpha Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2936788
other concurrent hormonal therapy
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
any concurrent radiotherapy
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
testosterone at screening <= 1.7 mm or 50 ng/dl
Description

Testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523912
clinically significant elevation of serum creatinine or liver enzymes
Description

Serum creatinine raised | Elevated liver enzymes

Data type

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C0235996
hypersensitivity to gnrh or other gnrh analogues or leuprorelin acetate
Description

Hypersensitivity GnRH | Hypersensitivity GnRH Analog | Hypersensitivity Leuprorelin Acetate

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0023610
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1518041
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0700596
hypersensitivity to casodexâ 50 mg.
Description

Hypersensitivity Casodex

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0591237
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Similar models

Eligibility Prostate Cancer NCT00378690

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Start time
Item
at study entry (visit 1):
boolean
C0008976 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
male subjects aged >=18 and <80 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Prostate carcinoma Advanced Local TNM clinical staging | Prostate cancer recurrent Post Radical prostatectomy | Prostate cancer recurrent Post Therapeutic radiology procedure
Item
locally advanced (stage t3 or t4) prostate cancer or relapsing prostate cancer following radical prostatectomy or,relapsing prostate cancer following radiotherapy
boolean
C0600139 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278838 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
C0278838 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
Gleason score
Item
gleason score of >=6
boolean
C3203027 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy at least 5 years
boolean
C0023671 (UMLS CUI [1])
Randomization Timepoint
Item
at randomization (visit 4):
boolean
C0034656 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Prostatic specific antigen decreased Levels Quantity
Item
two successive decreasing serum psa levels <=1 ng/ml
boolean
C0178414 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Start time
Item
at study entry (visit 1):
boolean
C0008976 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Second Primary Cancers Suspected
Item
any suspected second primary tumors
boolean
C0751623 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
Neoplasm Metastasis Evidence of
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Malignant Neoplasms
Item
other malignancy within the last 5 years except
boolean
C0006826 (UMLS CUI [1])
Compression of spinal cord | Ureteral obstruction Unilateral | Ureteral obstruction Bilateral
Item
acute spinal cord compression, uni- or bilateral ureteric obstruction
boolean
C0037926 (UMLS CUI [1])
C0041956 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0041956 (UMLS CUI [3,1])
C0238767 (UMLS CUI [3,2])
Biological Response Modifier Therapy
Item
any concurrent biological response modifier therapy
boolean
C0005527 (UMLS CUI [1])
Chemotherapy
Item
concurrent chemotherapy
boolean
C0392920 (UMLS CUI [1])
Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant
Item
less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
5-alpha Reductase Inhibitors
Item
less than 6 months since prior 5-alpha reductase inhibitor treatment
boolean
C2936788 (UMLS CUI [1])
Hormone Therapy
Item
other concurrent hormonal therapy
boolean
C0279025 (UMLS CUI [1])
Therapeutic radiology procedure
Item
any concurrent radiotherapy
boolean
C1522449 (UMLS CUI [1])
Testosterone measurement
Item
testosterone at screening <= 1.7 mm or 50 ng/dl
boolean
C0523912 (UMLS CUI [1])
Serum creatinine raised | Elevated liver enzymes
Item
clinically significant elevation of serum creatinine or liver enzymes
boolean
C0700225 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
Hypersensitivity GnRH | Hypersensitivity GnRH Analog | Hypersensitivity Leuprorelin Acetate
Item
hypersensitivity to gnrh or other gnrh analogues or leuprorelin acetate
boolean
C0020517 (UMLS CUI [1,1])
C0023610 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1518041 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0700596 (UMLS CUI [3,2])
Hypersensitivity Casodex
Item
hypersensitivity to casodexâ 50 mg.
boolean
C0020517 (UMLS CUI [1,1])
C0591237 (UMLS CUI [1,2])
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