ID

22710

Description

Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01825642

Link

https://clinicaltrials.gov/show/NCT01825642

Keywords

Versions (1)
  1. 6/10/17 6/10/17 -
Uploaded on

June 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01825642

English

Eligibility Prostate Cancer NCT01825642

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men with biopsy-proven histologic diagnosis of prostate adenocarcinoma
Description

gender, histologically confirmed adenocarcinoma of the prostate

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0679557
UMLS CUI [2,2]
C0007112
low risk for seminal vesicle invasions defined by:
Description

low risk for seminal vesicle invasions

Data type

boolean

Alias
UMLS CUI [1,1]
C3538919
UMLS CUI [1,2]
C1718327
clinical stage t1c/tumor 2-node 0-metastasis 0, gleason score ≤ 6, psa ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage t1c/t2n0m0, gleason ≤ 7, psa ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%)
Description

clinical TNM stage, gleason, psa, positive prostate biopsy core proportion

Data type

boolean

Alias
UMLS CUI [1]
C1707417
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
UMLS CUI [4,1]
C0194804
UMLS CUI [4,2]
C1446409
UMLS CUI [4,3]
C0444669
UMLS CUI [4,4]
C1709707
sexually potent, defined as international index of erectile function score ≥ 21, prior to randomization and surgery
Description

international index of erectile function score

Data type

boolean

Alias
UMLS CUI [1]
C2959364
competent to provide informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
able to read and write english
Description

english

Data type

boolean

Alias
UMLS CUI [1]
C0376245
candidate for bilateral nerve-sparing
Description

bilateral nerve-sparing

Data type

boolean

Alias
UMLS CUI [1]
C0444743
willing to be followed for 12 months post-surgery
Description

compliance follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1522577
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
intermediate or high risk for seminal vesicle invasion
Description

intermediate or high risk for seminal vesicle invasion

Data type

boolean

Alias
UMLS CUI [1,1]
C3640764
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C1718327
unwilling to be randomized to either treatment arm
Description

unwilling to be randomized

Data type

boolean

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0034656
pre-operative treatment with radiation and/or hormone therapy
Description

pre-operative treatment with radiation and/or hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C1514460
planned adjuvant radiation and/or hormonal therapy
Description

planned adjuvant radiation and/or hormonal therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C1706721
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C1971498
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Similar models

Eligibility Prostate Cancer NCT01825642

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
gender, histologically confirmed adenocarcinoma of the prostate
Item
men with biopsy-proven histologic diagnosis of prostate adenocarcinoma
boolean
C0079399 (UMLS CUI [1])
C0679557 (UMLS CUI [2,1])
C0007112 (UMLS CUI [2,2])
low risk for seminal vesicle invasions
Item
low risk for seminal vesicle invasions defined by:
boolean
C3538919 (UMLS CUI [1,1])
C1718327 (UMLS CUI [1,2])
clinical TNM stage, gleason, psa, positive prostate biopsy core proportion
Item
clinical stage t1c/tumor 2-node 0-metastasis 0, gleason score ≤ 6, psa ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage t1c/t2n0m0, gleason ≤ 7, psa ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%)
boolean
C1707417 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
C0194804 (UMLS CUI [4,1])
C1446409 (UMLS CUI [4,2])
C0444669 (UMLS CUI [4,3])
C1709707 (UMLS CUI [4,4])
international index of erectile function score
Item
sexually potent, defined as international index of erectile function score ≥ 21, prior to randomization and surgery
boolean
C2959364 (UMLS CUI [1])
informed consent
Item
competent to provide informed consent
boolean
C0021430 (UMLS CUI [1])
english
Item
able to read and write english
boolean
C0376245 (UMLS CUI [1])
bilateral nerve-sparing
Item
candidate for bilateral nerve-sparing
boolean
C0444743 (UMLS CUI [1])
compliance follow-up
Item
willing to be followed for 12 months post-surgery
boolean
C1321605 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
intermediate or high risk for seminal vesicle invasion
Item
intermediate or high risk for seminal vesicle invasion
boolean
C3640764 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C1718327 (UMLS CUI [1,3])
unwilling to be randomized
Item
unwilling to be randomized to either treatment arm
boolean
C0558080 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
pre-operative treatment with radiation and/or hormone therapy
Item
pre-operative treatment with radiation and/or hormone therapy
boolean
C0279134 (UMLS CUI [1])
C1514460 (UMLS CUI [2])
planned adjuvant radiation and/or hormonal therapy
Item
planned adjuvant radiation and/or hormonal therapy
boolean
C1301732 (UMLS CUI [1,1])
C1706721 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C1971498 (UMLS CUI [2,2])
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