ID

14617

Description

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00005947

Lien

https://clinicaltrials.gov/show/NCT00005947

Mots-clés

Versions (1)
  1. 24/04/2016 24/04/2016 -
Téléchargé le

24 avril 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00005947

Anglais

Eligibility Prostate Cancer NCT00005947

1 Formulaires  
Criteria
Description

Criteria

metastatic disease as evidenced by soft tissue and/or bony metastases.
Description

Metastatic prostate cancer

Type de données

boolean

Alias
UMLS CUI [1]
C0936223
baseline psa value of at least 5 ng/ml. all subjects must have stable or rising psa.
Description

PSA measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201544
tumor progression after hormonal therapy.
Description

Tumor progression after hormonal therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0178874
UMLS CUI [1,2]
C0279025
hormonal therapy consisting of castration by orchiectomy or lhrh agonists for treatment of prostate cancer. castration levels of testosterone (< 50 ng/dl) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.
Description

Hormone therapy: specification

Type de données

boolean

Alias
UMLS CUI [1]
C0029189
UMLS CUI [2]
C1518041
UMLS CUI [3]
C0202227
a subject is eligible if he initially responded to antiandrogen withdrawal (> 25% decrease in psa) but at the time of registration demonstrated tumor progression. a subject is eligible if he failed to respond to antiandrogen withdrawal.
Description

Antiandrogen therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C0683154
subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.
Description

Cancer-related pain and analgesics

Type de données

boolean

Alias
UMLS CUI [1]
C1719395
UMLS CUI [2]
C0002771
ecog performance status of 0 or 1.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 16 weeks.
Description

Life expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
adequate hematologic, renal, and liver function.
Description

Hematologic, renal, and liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
exclusion criteria include:
Description

Exclusion criteria

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).
Description

Visceral organ metastases and effusions

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
UMLS CUI [2]
C0013687
metastatic disease expected to be in need of radiation therapy within 4 months.
Description

Metastatic disease need radiotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1522449
concurrent therapy with experimental agents.
Description

Experimental drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0304229
systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
Description

Systemic corticosteroids daily dose

Type de données

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C2348070
please note that there are additional eligibility criteria. the study center will determine if you meet all of the criteria.
Description

Eligibility criteria

Type de données

boolean

Alias
UMLS CUI [1]
C1516637
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Similar models

Eligibility Prostate Cancer NCT00005947

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Metastatic prostate cancer
Item
metastatic disease as evidenced by soft tissue and/or bony metastases.
boolean
C0936223 (UMLS CUI [1])
PSA measurement
Item
baseline psa value of at least 5 ng/ml. all subjects must have stable or rising psa.
boolean
C0201544 (UMLS CUI [1])
Tumor progression after hormonal therapy
Item
tumor progression after hormonal therapy.
boolean
C0178874 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Hormone therapy: specification
Item
hormonal therapy consisting of castration by orchiectomy or lhrh agonists for treatment of prostate cancer. castration levels of testosterone (< 50 ng/dl) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.
boolean
C0029189 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C0202227 (UMLS CUI [3])
Antiandrogen therapy
Item
a subject is eligible if he initially responded to antiandrogen withdrawal (> 25% decrease in psa) but at the time of registration demonstrated tumor progression. a subject is eligible if he failed to respond to antiandrogen withdrawal.
boolean
C0002842 (UMLS CUI [1,1])
C0683154 (UMLS CUI [1,2])
Cancer-related pain and analgesics
Item
subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.
boolean
C1719395 (UMLS CUI [1])
C0002771 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Life expectancy
Item
life expectancy of at least 16 weeks.
boolean
C0023671 (UMLS CUI [1])
Hematologic, renal, and liver function
Item
adequate hematologic, renal, and liver function.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Exclusion criteria
Item
exclusion criteria include:
boolean
C0680251 (UMLS CUI [1])
Visceral organ metastases and effusions
Item
visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0013687 (UMLS CUI [2])
Metastatic disease need radiotherapy
Item
metastatic disease expected to be in need of radiation therapy within 4 months.
boolean
C0027627 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Experimental drugs
Item
concurrent therapy with experimental agents.
boolean
C0304229 (UMLS CUI [1])
Systemic corticosteroids daily dose
Item
systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
boolean
C2825233 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Eligibility criteria
Item
please note that there are additional eligibility criteria. the study center will determine if you meet all of the criteria.
boolean
C1516637 (UMLS CUI [1])
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