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

Lien

https://clinicaltrials.gov/show/NCT01446991

Mots-clés

  1. 13/03/2016 13/03/2016 -
Téléchargé le

13 mars 2016

DOI

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Licence

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

pelvic radiotherapy

Type de données

boolean

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

informed consent

Type de données

boolean

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

prostate brachytherapy; Antiandrogen therapy

Type de données

boolean

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

Study Subject Participation Status

Type de données

boolean

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

Transurethral Resection of Prostate

Type de données

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

Type de données

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

Type de données

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)
Type de données
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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