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ID

13874

Description

Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01446991

Link

https://clinicaltrials.gov/show/NCT01446991

Keywords

  1. 3/13/16 3/13/16 -
Uploaded on

March 13, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Prostate Cancer NCT01446991

    Eligibility Prostate Cancer NCT01446991

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologic diagnosis of prostate cancer
    Description

    prostate cancer

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0600139
    favorable risk disease (ct1 or t2a, gleason score (gs) 6, and prostate specific antigen (psa) < 10 ng/ml)
    Description

    tumor stage; gleason score; prostate specific antigen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1300072
    UMLS CUI [2]
    C3203027
    UMLS CUI [3]
    C0138741
    low-tier intermediate risk disease (ct2c,gs=6,and psa 10-15 ng/ml, or gs=7 and psa < 10 ng/ml)
    Description

    tumor stage; gleason score; prostate specific antigen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1300072
    UMLS CUI [2]
    C3203027
    UMLS CUI [3]
    C0138741
    intermediate risk disease and androgen deprivation therapy recommended by the treating physician for oncologic reasons such as (≥ 50% positive biopsy cores,ct2c,psa 15-20 ng/ml,gs=7)
    Description

    Antiandrogen therapy; positive biopsy cores; tumor stage; gleason score; prostate specific antigen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0279492
    UMLS CUI [2]
    C1276779
    UMLS CUI [3]
    C1300072
    UMLS CUI [4]
    C3203027
    UMLS CUI [5]
    C0138741
    patient requires baseline planning trans-rectal ultrasound for the purposes of prostate brachytherapy, showing prostate volume > 40 ml and pubic arch interference (not required for those requiring androgen ablation for oncologic reasons)
    Description

    trans-rectal ultrasound prostate volume for prostate brachytherapy; androgen ablation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0812546
    UMLS CUI [2]
    C1515985
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    castrate serum testosterone level
    Description

    serum testosterone

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428413
    previous or concurrent pelvic radiotherapy
    Description

    pelvic radiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0436276
    unable to give written informed consent
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    contraindications to permanent seed prostate brachytherapy or to androgen deprivation therapy
    Description

    prostate brachytherapy; Antiandrogen therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0854662
    UMLS CUI [2]
    C0279492
    prior treatment for prostate cancer
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    prior trans-urethral resection of the prostate
    Description

    Transurethral Resection of Prostate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0040771
    previous therapy with a 5-α reductase inhibitor, anti-androgen agent, or lhrh agonist
    Description

    therapy 5-alpha Reductase Inhibitors Androgen Antagonists; Luteinizing Hormone-releasing Hormone Agonist

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2936788
    UMLS CUI [1,3]
    C0002842
    UMLS CUI [1,4]
    C1518041
    previous therapy with degarelix
    Description

    therapy degarelix

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1455035

    Similar models

    Eligibility Prostate Cancer NCT01446991

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    prostate cancer
    Item
    histologic diagnosis of prostate cancer
    boolean
    C0600139 (UMLS CUI [1])
    tumor stage; gleason score; prostate specific antigen
    Item
    favorable risk disease (ct1 or t2a, gleason score (gs) 6, and prostate specific antigen (psa) < 10 ng/ml)
    boolean
    C1300072 (UMLS CUI [1])
    C3203027 (UMLS CUI [2])
    C0138741 (UMLS CUI [3])
    tumor stage; gleason score; prostate specific antigen
    Item
    low-tier intermediate risk disease (ct2c,gs=6,and psa 10-15 ng/ml, or gs=7 and psa < 10 ng/ml)
    boolean
    C1300072 (UMLS CUI [1])
    C3203027 (UMLS CUI [2])
    C0138741 (UMLS CUI [3])
    Antiandrogen therapy; positive biopsy cores; tumor stage; gleason score; prostate specific antigen
    Item
    intermediate risk disease and androgen deprivation therapy recommended by the treating physician for oncologic reasons such as (≥ 50% positive biopsy cores,ct2c,psa 15-20 ng/ml,gs=7)
    boolean
    C0279492 (UMLS CUI [1])
    C1276779 (UMLS CUI [2])
    C1300072 (UMLS CUI [3])
    C3203027 (UMLS CUI [4])
    C0138741 (UMLS CUI [5])
    trans-rectal ultrasound prostate volume for prostate brachytherapy; androgen ablation
    Item
    patient requires baseline planning trans-rectal ultrasound for the purposes of prostate brachytherapy, showing prostate volume > 40 ml and pubic arch interference (not required for those requiring androgen ablation for oncologic reasons)
    boolean
    C0812546 (UMLS CUI [1])
    C1515985 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    serum testosterone
    Item
    castrate serum testosterone level
    boolean
    C0428413 (UMLS CUI [1])
    pelvic radiotherapy
    Item
    previous or concurrent pelvic radiotherapy
    boolean
    C0436276 (UMLS CUI [1])
    informed consent
    Item
    unable to give written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    prostate brachytherapy; Antiandrogen therapy
    Item
    contraindications to permanent seed prostate brachytherapy or to androgen deprivation therapy
    boolean
    C0854662 (UMLS CUI [1])
    C0279492 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    prior treatment for prostate cancer
    boolean
    C2348568 (UMLS CUI [1])
    Transurethral Resection of Prostate
    Item
    prior trans-urethral resection of the prostate
    boolean
    C0040771 (UMLS CUI [1])
    therapy 5-alpha Reductase Inhibitors Androgen Antagonists; Luteinizing Hormone-releasing Hormone Agonist
    Item
    previous therapy with a 5-α reductase inhibitor, anti-androgen agent, or lhrh agonist
    boolean
    C0087111 (UMLS CUI [1,1])
    C2936788 (UMLS CUI [1,2])
    C0002842 (UMLS CUI [1,3])
    C1518041 (UMLS CUI [1,4])
    therapy degarelix
    Item
    previous therapy with degarelix
    boolean
    C0087111 (UMLS CUI [1,1])
    C1455035 (UMLS CUI [1,2])

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