ID

14617

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00005947

Palabras clave

Versiones (1)
  1. 24/4/16 24/4/16 -
Subido en

24 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00005947

Inglés

Eligibility Prostate Cancer NCT00005947

1 formularios  
Criteria
Descripción

Criteria

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

Metastatic prostate cancer

Tipo de datos

boolean

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

PSA measurement

Tipo de datos

boolean

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

Tumor progression after hormonal therapy

Tipo de datos

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.
Descripción

Hormone therapy: specification

Tipo de datos

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.
Descripción

Antiandrogen therapy

Tipo de datos

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.
Descripción

Cancer-related pain and analgesics

Tipo de datos

boolean

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

ECOG performance status

Tipo de datos

boolean

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

Life expectancy

Tipo de datos

boolean

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

Hematologic, renal, and liver function

Tipo de datos

boolean

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

Exclusion criteria

Tipo de datos

boolean

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

Visceral organ metastases and effusions

Tipo de datos

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.
Descripción

Metastatic disease need radiotherapy

Tipo de datos

boolean

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

Experimental drugs

Tipo de datos

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.
Descripción

Systemic corticosteroids daily dose

Tipo de datos

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.
Descripción

Eligibility criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516637
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Similar models

Eligibility Prostate Cancer NCT00005947

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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