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ID

14617

Beschreibung

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

Stichworte

Versionen (1)
  1. 24.04.16 24.04.16 -
Hochgeladen am

24. April 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Prostate Cancer NCT00005947

    Englisch

    Eligibility Prostate Cancer NCT00005947

    1 Formulare  
    Criteria
    Beschreibung

    Criteria

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

    Metastatic prostate cancer

    Datentyp

    boolean

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

    PSA measurement

    Datentyp

    boolean

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

    Tumor progression after hormonal therapy

    Datentyp

    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.
    Beschreibung

    Hormone therapy: specification

    Datentyp

    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.
    Beschreibung

    Antiandrogen therapy

    Datentyp

    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.
    Beschreibung

    Cancer-related pain and analgesics

    Datentyp

    boolean

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

    ECOG performance status

    Datentyp

    boolean

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

    Life expectancy

    Datentyp

    boolean

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

    Hematologic, renal, and liver function

    Datentyp

    boolean

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

    Exclusion criteria

    Datentyp

    boolean

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

    Visceral organ metastases and effusions

    Datentyp

    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.
    Beschreibung

    Metastatic disease need radiotherapy

    Datentyp

    boolean

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

    Experimental drugs

    Datentyp

    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.
    Beschreibung

    Systemic corticosteroids daily dose

    Datentyp

    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.
    Beschreibung

    Eligibility criteria

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Prostate Cancer NCT00005947

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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