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

Link

https://clinicaltrials.gov/show/NCT00005947

Keywords

Versions (1)
  1. 4/24/16 4/24/16 -
Uploaded on

April 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00005947

English

Eligibility Prostate Cancer NCT00005947

1 forms  
Criteria
Description

Criteria

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

Metastatic prostate cancer

Data type

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

Data type

boolean

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

Tumor progression after hormonal therapy

Data type

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

Data type

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

Data type

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

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Life expectancy

Data type

boolean

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

Hematologic, renal, and liver function

Data type

boolean

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

Exclusion criteria

Data type

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

Data type

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

Data type

boolean

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

Experimental drugs

Data type

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

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C1516637
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Similar models

Eligibility Prostate Cancer NCT00005947

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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