ID

31588

Description

Open-label Extension Study of the Effects of Pomegranate Extract on Rising PSA After Primary Therapy for Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00731848

Link

https://clinicaltrials.gov/show/NCT00731848

Keywords

Versions (2)
  1. 9/8/18 9/8/18 -
  2. 9/9/18 9/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 8, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostate Cancer NCT00731848

English

Eligibility Prostate Cancer NCT00731848

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented disease progression while on placebo in the gup-0205-1 or gup-0205-1xx study (a ≥100% increase over baseline serum psa with a minimum increase of 1.0 ng/ml.
Description

Disease Progression | Placebo given | Raised prostate specific antigen

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0420256
UMLS CUI [3]
C0178415
willingness and ability to sign an informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
Description

Pomegranate Extract Other Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1961993
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) are acceptable provided the dose has been stable for at least 2 months prior to screening and the subject agrees not to change/stop during the course of the study.
Description

Dietary Supplements Dose Stable | Herbal Supplements Dose Stable | Saw palmetto extract | Selenium

Data type

boolean

Alias
UMLS CUI [1,1]
C0242295
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1504473
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0771607
UMLS CUI [4]
C0036581
performance status 0 or 1 on the ecog scale at time of entry into this extension study.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the subject a poor protocol candidate.
Description

Comorbidity Study Subject Participation Status Poor | Mental condition Study Subject Participation Status Poor

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2700379
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2700379
hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (adt) prior to or concurrent with primary therapy. subjects who underwent neoadjuvant adt cannot have a serum testosterone of ≤150 ng/ml at study entry.
Description

Hormone Therapy | Exception Antiandrogen therapy Neoadjuvant | Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279492
UMLS CUI [2,3]
C0600558
UMLS CUI [3]
C0428413
concomitant or antecedent hormonal therapy for rising serum psa after initial therapy of prostate cancer.
Description

Hormone Therapy | Raised prostate specific antigen | Status post Induction Therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0178415
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C0600139
subjects unable or unwilling to comply with protocol requirements.
Description

Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
Description

Experimental drug | Steroids High dose | Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0444956
UMLS CUI [3]
C0920425
serum psa >7.0 ng/ml (assessed at termination of the double-blind study or et of the double-blind extension gup-0205-1xx); at any psa level, the subject will be excluded if determined by the investigator that the subject's continued participation would not be in their best interest).
Description

Prostate specific antigen measurement | Study Subject Participation Status Unfavorable

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C3640815
serum psa doubling time <13 weeks (assessed at termination of the double-blind study or et of the double-blind extension gup-0205-1xx)).
Description

Prostate-Specific Antigen Doubling Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C2986483
evidence of metastatic disease on physical examination or on ct or bone scan.
Description

Neoplasm Metastasis Physical Examination | Neoplasm Metastasis CT | Neoplasm Metastasis Bone scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0203668
use of finasteride, dutasteride at any point since primary therapy or during the study.
Description

Finasteride | Dutasteride

Data type

boolean

Alias
UMLS CUI [1]
C0060389
UMLS CUI [2]
C0754659
clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (>2xuln).
Description

Raised laboratory findings

Data type

boolean

Alias
UMLS CUI [1]
C0586721
Back to the top of the page

Similar models

Eligibility Prostate Cancer NCT00731848

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Disease Progression | Placebo given | Raised prostate specific antigen
Item
documented disease progression while on placebo in the gup-0205-1 or gup-0205-1xx study (a ≥100% increase over baseline serum psa with a minimum increase of 1.0 ng/ml.
boolean
C0242656 (UMLS CUI [1])
C0420256 (UMLS CUI [2])
C0178415 (UMLS CUI [3])
Informed Consent
Item
willingness and ability to sign an informed consent document.
boolean
C0021430 (UMLS CUI [1])
Pomegranate Extract Other Absent
Item
agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
boolean
C1961993 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Dietary Supplements Dose Stable | Herbal Supplements Dose Stable | Saw palmetto extract | Selenium
Item
use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) are acceptable provided the dose has been stable for at least 2 months prior to screening and the subject agrees not to change/stop during the course of the study.
boolean
C0242295 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1504473 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0771607 (UMLS CUI [3])
C0036581 (UMLS CUI [4])
ECOG performance status
Item
performance status 0 or 1 on the ecog scale at time of entry into this extension study.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Study Subject Participation Status Poor | Mental condition Study Subject Participation Status Poor
Item
significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the subject a poor protocol candidate.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2700379 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2700379 (UMLS CUI [2,3])
Hormone Therapy | Exception Antiandrogen therapy Neoadjuvant | Serum testosterone measurement
Item
hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (adt) prior to or concurrent with primary therapy. subjects who underwent neoadjuvant adt cannot have a serum testosterone of ≤150 ng/ml at study entry.
boolean
C0279025 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0279492 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
C0428413 (UMLS CUI [3])
Hormone Therapy | Raised prostate specific antigen | Status post Induction Therapy Prostate carcinoma
Item
concomitant or antecedent hormonal therapy for rising serum psa after initial therapy of prostate cancer.
boolean
C0279025 (UMLS CUI [1])
C0178415 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0600139 (UMLS CUI [3,3])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
subjects unable or unwilling to comply with protocol requirements.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Experimental drug | Steroids High dose | Cancer treatment
Item
prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
boolean
C0304229 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3])
Prostate specific antigen measurement | Study Subject Participation Status Unfavorable
Item
serum psa >7.0 ng/ml (assessed at termination of the double-blind study or et of the double-blind extension gup-0205-1xx); at any psa level, the subject will be excluded if determined by the investigator that the subject's continued participation would not be in their best interest).
boolean
C0201544 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C3640815 (UMLS CUI [2,2])
Prostate-Specific Antigen Doubling Time
Item
serum psa doubling time <13 weeks (assessed at termination of the double-blind study or et of the double-blind extension gup-0205-1xx)).
boolean
C0138741 (UMLS CUI [1,1])
C2986483 (UMLS CUI [1,2])
Neoplasm Metastasis Physical Examination | Neoplasm Metastasis CT | Neoplasm Metastasis Bone scan
Item
evidence of metastatic disease on physical examination or on ct or bone scan.
boolean
C0027627 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
Finasteride | Dutasteride
Item
use of finasteride, dutasteride at any point since primary therapy or during the study.
boolean
C0060389 (UMLS CUI [1])
C0754659 (UMLS CUI [2])
Raised laboratory findings
Item
clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (>2xuln).
boolean
C0586721 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial