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ID

13874

Beschrijving

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

Trefwoorden

  1. 13-03-16 13-03-16 -
Geüploaded op

13 maart 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Prostate Cancer NCT01446991

    Eligibility Prostate Cancer NCT01446991

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologic diagnosis of prostate cancer
    Beschrijving

    prostate cancer

    Datatype

    boolean

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

    tumor stage; gleason score; prostate specific antigen

    Datatype

    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)
    Beschrijving

    tumor stage; gleason score; prostate specific antigen

    Datatype

    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)
    Beschrijving

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

    Datatype

    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)
    Beschrijving

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

    Datatype

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    castrate serum testosterone level
    Beschrijving

    serum testosterone

    Datatype

    boolean

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

    pelvic radiotherapy

    Datatype

    boolean

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

    informed consent

    Datatype

    boolean

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

    prostate brachytherapy; Antiandrogen therapy

    Datatype

    boolean

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

    Study Subject Participation Status

    Datatype

    boolean

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

    Transurethral Resection of Prostate

    Datatype

    boolean

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

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

    Datatype

    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
    Beschrijving

    therapy degarelix

    Datatype

    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)
    Datatype
    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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