ID

34247

Description

Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg; ODM derived from: https://clinicaltrials.gov/show/NCT01257425

Link

https://clinicaltrials.gov/show/NCT01257425

Keywords

Versions (1)
  1. 1/15/19 1/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01257425

English

Eligibility Prostate Cancer NCT01257425

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising psa (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
Description

Prostate carcinoma Advanced Locally | Metastatic Prostate Carcinoma | Raised prostate specific antigen | Status post Local Therapy failed | Antiandrogen therapy Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0936223
UMLS CUI [3]
C0178415
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1517925
UMLS CUI [4,3]
C0231175
UMLS CUI [5,1]
C0279492
UMLS CUI [5,2]
C0205539
serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
Description

Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428413
karnofsky performance index > 70
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
expected survival ≥ 9 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (gnrh) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
Description

Prior Hormone Therapy Prostate carcinoma | GnRH agonists Quantity | GnRH antagonist Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C2012324
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1268855
UMLS CUI [3,2]
C1265611
any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
Description

Pharmaceutical Preparations Affecting Metabolism | Pharmaceutical Preparations Affecting Androgen secretion | Ketoconazole | Aminoglutethimide | Estrogens | Progesterone

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0025519
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C3271399
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0002555
UMLS CUI [5]
C0014939
UMLS CUI [6]
C0033308
patient at risk of spinal cord compression or ureter obstruction
Description

At risk Compression of spinal cord | At risk Ureteral obstruction

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0037926
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0041956
prior hypophysectomy or adrenalectomy
Description

Hypophysectomy | Adrenalectomy

Data type

boolean

Alias
UMLS CUI [1]
C0020632
UMLS CUI [2]
C0001632
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Similar models

Eligibility Prostate Cancer NCT01257425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma Advanced Locally | Metastatic Prostate Carcinoma | Raised prostate specific antigen | Status post Local Therapy failed | Antiandrogen therapy Scheduled
Item
histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising psa (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
boolean
C0600139 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0936223 (UMLS CUI [2])
C0178415 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C1517925 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
C0279492 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
Serum testosterone measurement
Item
serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
boolean
C0428413 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance index > 70
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
expected survival ≥ 9 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Hormone Therapy Prostate carcinoma | GnRH agonists Quantity | GnRH antagonist Quantity
Item
prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (gnrh) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
boolean
C1514460 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C2012324 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1268855 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Pharmaceutical Preparations Affecting Metabolism | Pharmaceutical Preparations Affecting Androgen secretion | Ketoconazole | Aminoglutethimide | Estrogens | Progesterone
Item
any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0025519 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C3271399 (UMLS CUI [2,3])
C0022625 (UMLS CUI [3])
C0002555 (UMLS CUI [4])
C0014939 (UMLS CUI [5])
C0033308 (UMLS CUI [6])
At risk Compression of spinal cord | At risk Ureteral obstruction
Item
patient at risk of spinal cord compression or ureter obstruction
boolean
C1444641 (UMLS CUI [1,1])
C0037926 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C0041956 (UMLS CUI [2,2])
Hypophysectomy | Adrenalectomy
Item
prior hypophysectomy or adrenalectomy
boolean
C0020632 (UMLS CUI [1])
C0001632 (UMLS CUI [2])
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