ID

31590

Beschrijving

Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00732043

Link

https://clinicaltrials.gov/show/NCT00732043

Trefwoorden

Versies (1)
  1. 09-09-18 09-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 september 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00732043

Engels

Eligibility Prostate Cancer NCT00732043

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
no evidence of disease progression while on any of the three gup-0205 study products (disease progression defined as > 100% increase in serum psa [with a minimum value of 1.0 ng/ml]).
Beschrijving

Disease Progression Absent | Product Clinical Trial Specified | Raised prostate specific antigen Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1254351
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C0332197
willingness and ability to sign an informed consent document.
Beschrijving

Informed Consent

Datatype

boolean

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

Pomegranate Extract Other Absent

Datatype

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) is acceptable provided the dose has been stable during the course of the gup-0205- 1 study.
Beschrijving

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

Datatype

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
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant concomitant medical or psychiatric condition that, in the opinion of the principal investigator, would put the subject at risk or compromise the protocol.
Beschrijving

Comorbidity Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Comorbidity compromises Study Protocol | Mental condition compromises Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C2348563
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C2348563
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.
Beschrijving

Hormone Therapy | Exception Antiandrogen therapy Neoadjuvant | Serum testosterone measurement

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Protocol Compliance Unable | Protocol Compliance Unwilling

Datatype

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.
Beschrijving

Experimental drug | Steroids High dose | Cancer treatment

Datatype

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; at any psa level, the subject will be excluded if determined by the principal investigator that the subject's continued participation would not be in their best interest).
Beschrijving

Raised prostate specific antigen | Prostate specific antigen measurement | Study Subject Participation Status Unfavorable

Datatype

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2]
C0201544
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C3640815
serum psa doubling time <13 weeks (assessed at termination of the double-blind study).
Beschrijving

Prostate-Specific Antigen Doubling Time

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Finasteride | Dutasteride

Datatype

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).
Beschrijving

Raised laboratory findings

Datatype

boolean

Alias
UMLS CUI [1]
C0586721
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Similar models

Eligibility Prostate Cancer NCT00732043

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Disease Progression Absent | Product Clinical Trial Specified | Raised prostate specific antigen Absent
Item
no evidence of disease progression while on any of the three gup-0205 study products (disease progression defined as > 100% increase in serum psa [with a minimum value of 1.0 ng/ml]).
boolean
C0242656 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1254351 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0178415 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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) is acceptable provided the dose has been stable during the course of the gup-0205- 1 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])
Item Group
C0680251 (UMLS CUI)
Comorbidity Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Comorbidity compromises Study Protocol | Mental condition compromises Study Protocol
Item
significant concomitant medical or psychiatric condition that, in the opinion of the principal investigator, would put the subject at risk or compromise the protocol.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
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])
Raised prostate specific antigen | Prostate specific antigen measurement | Study Subject Participation Status Unfavorable
Item
serum psa >7.0 ng/ml (assessed at termination of the double-blind study; at any psa level, the subject will be excluded if determined by the principal investigator that the subject's continued participation would not be in their best interest).
boolean
C0178415 (UMLS CUI [1])
C0201544 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C3640815 (UMLS CUI [3,2])
Prostate-Specific Antigen Doubling Time
Item
serum psa doubling time <13 weeks (assessed at termination of the double-blind study).
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])
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