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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