ID

18913

Description

Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00060086

Link

https://clinicaltrials.gov/show/NCT00060086

Keywords

Versions (1)
  1. 11/24/16 11/24/16 -
Uploaded on

November 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00060086

English

Eligibility Prostate Cancer NCT00060086

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
must have undergone prior surgery or radiotherapy for the primary tumor
Description

Prior surgery primary tumor | prior radiation therapy primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0677930
documented rising prostate-specific antigen (psa) level, defined by the following criteria:
Description

Raised prostate specific antigen

Data type

boolean

Alias
UMLS CUI [1]
C0178415
absolute level of psa at least 0.2 ng/ml but less than 5.0 ng/ml
Description

Prostate specific antigen measurement Absolute

Data type

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0205344
rising psa level must be confirmed at least 1 week later
Description

Raised prostate specific antigen Confirmation Point in time

Data type

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C1442880
adequate psa time points to calculate a psa doubling time
Description

Prostate-Specific Antigen measurement Point in time Quantity | Calculation Prostate-Specific Antigen Doubling Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C1442880
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1441506
UMLS CUI [2,2]
C0138741
UMLS CUI [2,3]
C1705764
UMLS CUI [2,4]
C0040223
gleason score no greater than 7
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
age 18 and over
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status ecog 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy at least 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
no other malignancy within the past 5 years except nonmelanoma skin cancer
Description

Malignant Neoplasms | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
no other serious concurrent systemic medical disorders that would preclude study compliance
Description

Systemic disease Serious Excludes Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0525058
no known allergy to pomegranate juice
Description

Hypersensitivity POMEGRANATE JUICE

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1327962
more than 4 weeks since prior participation in another experimental study
Description

Study Subject Participation Status Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205156
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
nodal involvement
Description

nodal involvement

Data type

boolean

Alias
UMLS CUI [1]
C0441949
evidence of metastatic disease
Description

Neoplasm Metastasis Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
prior hormonal therapy
Description

Prior Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514460
concurrent hormonal therapy for rising psa levels after initial therapy for prostate cancer
Description

Therapeutic procedure Initial Prostate carcinoma | Hormone Therapy Raised prostate specific antigen

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0178415
concurrent participation in another experimental study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
other concurrent systemic or local therapy for prostate cancer
Description

systemic therapy Prostate carcinoma | Local Therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1517925
UMLS CUI [2,2]
C0600139
initiation or discontinuation of any new nutritional or dietary supplements during study participation
Description

Initiation Nutritional Supplements New | Discontinuation Nutritional Supplements New

Data type

boolean

Alias
UMLS CUI [1,1]
C1704686
UMLS CUI [1,2]
C0242295
UMLS CUI [1,3]
C0205314
UMLS CUI [2,1]
C0457454
UMLS CUI [2,2]
C0242295
UMLS CUI [2,3]
C0205314
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Similar models

Eligibility Prostate Cancer NCT00060086

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Prior surgery primary tumor | prior radiation therapy primary tumor
Item
must have undergone prior surgery or radiotherapy for the primary tumor
boolean
C0455610 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
Raised prostate specific antigen
Item
documented rising prostate-specific antigen (psa) level, defined by the following criteria:
boolean
C0178415 (UMLS CUI [1])
Prostate specific antigen measurement Absolute
Item
absolute level of psa at least 0.2 ng/ml but less than 5.0 ng/ml
boolean
C0201544 (UMLS CUI [1,1])
C0205344 (UMLS CUI [1,2])
Raised prostate specific antigen Confirmation Point in time
Item
rising psa level must be confirmed at least 1 week later
boolean
C0178415 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C1442880 (UMLS CUI [1,3])
Prostate-Specific Antigen measurement Point in time Quantity | Calculation Prostate-Specific Antigen Doubling Time
Item
adequate psa time points to calculate a psa doubling time
boolean
C0201544 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1441506 (UMLS CUI [2,1])
C0138741 (UMLS CUI [2,2])
C1705764 (UMLS CUI [2,3])
C0040223 (UMLS CUI [2,4])
Gleason score
Item
gleason score no greater than 7
boolean
C3203027 (UMLS CUI [1])
Age
Item
age 18 and over
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy at least 6 months
boolean
C0023671 (UMLS CUI [1])
Malignant Neoplasms | Skin carcinoma
Item
no other malignancy within the past 5 years except nonmelanoma skin cancer
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Systemic disease Serious Excludes Protocol Compliance
Item
no other serious concurrent systemic medical disorders that would preclude study compliance
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Hypersensitivity POMEGRANATE JUICE
Item
no known allergy to pomegranate juice
boolean
C0020517 (UMLS CUI [1,1])
C1327962 (UMLS CUI [1,2])
Study Subject Participation Status Previous
Item
more than 4 weeks since prior participation in another experimental study
boolean
C2348568 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
nodal involvement
Item
nodal involvement
boolean
C0441949 (UMLS CUI [1])
Neoplasm Metastasis Evidence of
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Prior Hormone Therapy
Item
prior hormonal therapy
boolean
C1514460 (UMLS CUI [1])
Therapeutic procedure Initial Prostate carcinoma | Hormone Therapy Raised prostate specific antigen
Item
concurrent hormonal therapy for rising psa levels after initial therapy for prostate cancer
boolean
C0087111 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0178415 (UMLS CUI [2,2])
Study Subject Participation Status
Item
concurrent participation in another experimental study
boolean
C2348568 (UMLS CUI [1])
systemic therapy Prostate carcinoma | Local Therapy Prostate carcinoma
Item
other concurrent systemic or local therapy for prostate cancer
boolean
C1515119 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1517925 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Initiation Nutritional Supplements New | Discontinuation Nutritional Supplements New
Item
initiation or discontinuation of any new nutritional or dietary supplements during study participation
boolean
C1704686 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
C0457454 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])
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