ID

31589

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00731848

Nyckelord

Versioner (2)
  1. 2018-09-08 2018-09-08 -
  2. 2018-09-09 2018-09-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00731848

Engelsk

Eligibility Prostate Cancer NCT00731848

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

Disease Progression | Placebo given | Raised prostate specific antigen

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

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

Pomegranate Extract Other Absent

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Hormone Therapy | Exception Antiandrogen therapy Neoadjuvant | Serum testosterone measurement

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Protocol Compliance Unable | Protocol Compliance Unwilling

Datatyp

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.
Beskrivning

Experimental drug | Steroids High dose | Cancer treatment

Datatyp

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).
Beskrivning

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

Datatyp

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 or et of the double-blind extension gup-0205-1xx)).
Beskrivning

Prostate-Specific Antigen Doubling Time

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Finasteride | Dutasteride

Datatyp

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).
Beskrivning

Raised laboratory findings

Datatyp

boolean

Alias
UMLS CUI [1]
C0586721
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Similar models

Eligibility Prostate Cancer NCT00731848

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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 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
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 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])
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