ID

31573

Beskrivning

Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00678015

Länk

https://clinicaltrials.gov/show/NCT00678015

Nyckelord

Versioner (1)
  1. 2018-09-06 2018-09-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00678015

Engelsk

Eligibility Prostate Cancer NCT00678015

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
rising prostate-specific antigen (psa) value after local therapy with a psa doubling time (psadt) between 6 and 24 months (four or more readings at least two weeks apart within the last six months)
Beskrivning

Raised prostate specific antigen Post Local Therapy | Prostate-Specific Antigen Doubling Time

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1517925
UMLS CUI [2,1]
C0138741
UMLS CUI [2,2]
C2986483
prior definitive therapy for prostate cancer consisting of one of the following:
Beskrivning

Definitive Treatment Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986592
UMLS CUI [1,2]
C0600139
1. external beam radiotherapy with or without hormone therapy
Beskrivning

External beam radiotherapy | Hormone Therapy | Hormone Therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0419095
UMLS CUI [2]
C0279025
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0332197
2. brachytherapy with or without pelvic external beam radiation or hormone therapy
Beskrivning

Brachytherapy | External beam radiotherapy Pelvis | Hormone Therapy Pelvis | External beam radiotherapy Absent Pelvis | Hormone Therapy Absent Pelvis

Datatyp

boolean

Alias
UMLS CUI [1]
C0006098
UMLS CUI [2,1]
C0419095
UMLS CUI [2,2]
C0030797
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0030797
UMLS CUI [4,1]
C0419095
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0030797
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0030797
3. radical prostatectomy with or without adjuvant or salvage radiation therapy
Beskrivning

Radical prostatectomy | Adjuvant Radiation Therapy | Salvage Therapeutic radiology procedure | Adjuvant Radiation Therapy Absent | Salvage Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0194810
UMLS CUI [2]
C1706721
UMLS CUI [3,1]
C0442967
UMLS CUI [3,2]
C1522449
UMLS CUI [4,1]
C1706721
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0442967
UMLS CUI [5,2]
C1522449
UMLS CUI [5,3]
C0332197
psa > 1 ng/ml, which has risen serially on two determinations at least one week apart
Beskrivning

Prostate specific antigen measurement | Raised prostate specific antigen Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
progressive disease by "phoenix" consensus definition for patients who have undergone primary radiation therapy (psa nadir + 2 ng/ml)
Beskrivning

Progressive Disease | Therapeutic radiology procedure Primary | Prostate specific antigen measurement Nadir

Datatyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C0201544
UMLS CUI [3,2]
C1708760
no metastatic disease
Beskrivning

Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
prior adjuvant or neoadjuvant androgen deprivation is permitted, provided:
Beskrivning

Antiandrogen therapy Adjuvant | Antiandrogen therapy Neoadjuvant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C1522673
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C0600558
1. > 6 months since last day of effective androgen deprivation
Beskrivning

Antiandrogen therapy Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0205156
2. testosterone > 250 ng/dl
Beskrivning

Testosterone measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0523912
3. patient is not on intermittent androgen deprivation
Beskrivning

Absence Antiandrogen therapy Intermittent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0279492
UMLS CUI [1,3]
C0205267
karnofsky performance status (kps) of > 70%
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
liver function tests are within normal range
Beskrivning

Liver Function Tests

Datatyp

boolean

Alias
UMLS CUI [1]
C0023901
glycated hemoglobin (hga1c) < 6%
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
patients must be four weeks from major surgery or radiotherapy to be eligible
Beskrivning

Major surgery Previous | Therapeutic radiology procedure Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205156
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of another active malignancy other than prostate cancer, or treated squamous/basal cell carcinoma of the skin. concomitant medical condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements
Beskrivning

Cancer Other | Exception Prostate carcinoma | Exception Squamous cell carcinoma of skin Treated | Exception Basal cell carcinoma Treated | Comorbidity Study Subject Participation Status Unfavorable | Comorbidity compromises Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C3640815
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C0525058
diabetes mellitus, unless diet-controlled
Beskrivning

Diabetes Mellitus | Exception Diet controlled Diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0421246
must be off saw palmetto, pomegranate juice, finasteride, or any herbal agent intended to lower psa for > 4 weeks. baseline psadt calculation must occur off of these agents
Beskrivning

Saw palmetto extract | POMEGRANATE JUICE | Finasteride | Herbal medicine PSA Lowering

Datatyp

boolean

Alias
UMLS CUI [1]
C0771607
UMLS CUI [2]
C1327962
UMLS CUI [3]
C0060389
UMLS CUI [4,1]
C2240391
UMLS CUI [4,2]
C0138741
UMLS CUI [4,3]
C2003888
patients may not have evidence of local-only recurrence of prostate cancer
Beskrivning

Prostate cancer recurrent Local

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0278838
UMLS CUI [1,2]
C0205276
no history of liver disease, including hepatitis b or c, alcoholic liver disease, or autoimmune liver disease. a prior history of hepatitis a is allowed provided that baseline liver function tests are within normal limits
Beskrivning

Liver disease | Hepatitis B | Hepatitis C | Alcoholic Liver Diseases | Autoimmune liver disease | Hepatitis A Previous allowed | Relationship Liver function tests normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0023896
UMLS CUI [5]
C0400936
UMLS CUI [6,1]
C0019159
UMLS CUI [6,2]
C0205156
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C0439849
UMLS CUI [7,2]
C0438235
patients with castration resistant prostate cancer are ineligible (prostate cancer which has progressed on androgen deprivation therapy with a luteinizing hormone-releasing hormone (lhrh)-agonist or orchiectomy)
Beskrivning

Castration-resistant prostate cancer | Antiandrogen therapy Prostate carcinoma progressed | LHRH Agonist Prostate carcinoma progressed | Orchiectomy Prostate carcinoma progressed

Datatyp

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C0600139
UMLS CUI [2,3]
C1272688
UMLS CUI [3,1]
C1518041
UMLS CUI [3,2]
C0600139
UMLS CUI [3,3]
C1272688
UMLS CUI [4,1]
C0029189
UMLS CUI [4,2]
C0600139
UMLS CUI [4,3]
C1272688
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Similar models

Eligibility Prostate Cancer NCT00678015

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Raised prostate specific antigen Post Local Therapy | Prostate-Specific Antigen Doubling Time
Item
rising prostate-specific antigen (psa) value after local therapy with a psa doubling time (psadt) between 6 and 24 months (four or more readings at least two weeks apart within the last six months)
boolean
C0178415 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1517925 (UMLS CUI [1,3])
C0138741 (UMLS CUI [2,1])
C2986483 (UMLS CUI [2,2])
Definitive Treatment Prostate carcinoma
Item
prior definitive therapy for prostate cancer consisting of one of the following:
boolean
C2986592 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
External beam radiotherapy | Hormone Therapy | Hormone Therapy Absent
Item
1. external beam radiotherapy with or without hormone therapy
boolean
C0419095 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Brachytherapy | External beam radiotherapy Pelvis | Hormone Therapy Pelvis | External beam radiotherapy Absent Pelvis | Hormone Therapy Absent Pelvis
Item
2. brachytherapy with or without pelvic external beam radiation or hormone therapy
boolean
C0006098 (UMLS CUI [1])
C0419095 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0030797 (UMLS CUI [3,2])
C0419095 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0030797 (UMLS CUI [4,3])
C0279025 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0030797 (UMLS CUI [5,3])
Radical prostatectomy | Adjuvant Radiation Therapy | Salvage Therapeutic radiology procedure | Adjuvant Radiation Therapy Absent | Salvage Therapeutic radiology procedure Absent
Item
3. radical prostatectomy with or without adjuvant or salvage radiation therapy
boolean
C0194810 (UMLS CUI [1])
C1706721 (UMLS CUI [2])
C0442967 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C1706721 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0442967 (UMLS CUI [5,1])
C1522449 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Prostate specific antigen measurement | Raised prostate specific antigen Quantity
Item
psa > 1 ng/ml, which has risen serially on two determinations at least one week apart
boolean
C0201544 (UMLS CUI [1])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Progressive Disease | Therapeutic radiology procedure Primary | Prostate specific antigen measurement Nadir
Item
progressive disease by "phoenix" consensus definition for patients who have undergone primary radiation therapy (psa nadir + 2 ng/ml)
boolean
C1335499 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3,1])
C1708760 (UMLS CUI [3,2])
Neoplasm Metastasis Absent
Item
no metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antiandrogen therapy Adjuvant | Antiandrogen therapy Neoadjuvant
Item
prior adjuvant or neoadjuvant androgen deprivation is permitted, provided:
boolean
C0279492 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0279492 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
Antiandrogen therapy Previous
Item
1. > 6 months since last day of effective androgen deprivation
boolean
C0279492 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Testosterone measurement
Item
2. testosterone > 250 ng/dl
boolean
C0523912 (UMLS CUI [1])
Absence Antiandrogen therapy Intermittent
Item
3. patient is not on intermittent androgen deprivation
boolean
C0332197 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
karnofsky performance status (kps) of > 70%
boolean
C0206065 (UMLS CUI [1])
Liver Function Tests
Item
liver function tests are within normal range
boolean
C0023901 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycated hemoglobin (hga1c) < 6%
boolean
C0474680 (UMLS CUI [1])
Major surgery Previous | Therapeutic radiology procedure Previous
Item
patients must be four weeks from major surgery or radiotherapy to be eligible
boolean
C0679637 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Prostate carcinoma | Exception Squamous cell carcinoma of skin Treated | Exception Basal cell carcinoma Treated | Comorbidity Study Subject Participation Status Unfavorable | Comorbidity compromises Protocol Compliance
Item
presence of another active malignancy other than prostate cancer, or treated squamous/basal cell carcinoma of the skin. concomitant medical condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C0009488 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C3640815 (UMLS CUI [5,3])
C0009488 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Diabetes Mellitus | Exception Diet controlled Diabetes mellitus
Item
diabetes mellitus, unless diet-controlled
boolean
C0011849 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0421246 (UMLS CUI [2,2])
Saw palmetto extract | POMEGRANATE JUICE | Finasteride | Herbal medicine PSA Lowering
Item
must be off saw palmetto, pomegranate juice, finasteride, or any herbal agent intended to lower psa for > 4 weeks. baseline psadt calculation must occur off of these agents
boolean
C0771607 (UMLS CUI [1])
C1327962 (UMLS CUI [2])
C0060389 (UMLS CUI [3])
C2240391 (UMLS CUI [4,1])
C0138741 (UMLS CUI [4,2])
C2003888 (UMLS CUI [4,3])
Prostate cancer recurrent Local
Item
patients may not have evidence of local-only recurrence of prostate cancer
boolean
C0278838 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Liver disease | Hepatitis B | Hepatitis C | Alcoholic Liver Diseases | Autoimmune liver disease | Hepatitis A Previous allowed | Relationship Liver function tests normal
Item
no history of liver disease, including hepatitis b or c, alcoholic liver disease, or autoimmune liver disease. a prior history of hepatitis a is allowed provided that baseline liver function tests are within normal limits
boolean
C0023895 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0023896 (UMLS CUI [4])
C0400936 (UMLS CUI [5])
C0019159 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0439849 (UMLS CUI [7,1])
C0438235 (UMLS CUI [7,2])
Castration-resistant prostate cancer | Antiandrogen therapy Prostate carcinoma progressed | LHRH Agonist Prostate carcinoma progressed | Orchiectomy Prostate carcinoma progressed
Item
patients with castration resistant prostate cancer are ineligible (prostate cancer which has progressed on androgen deprivation therapy with a luteinizing hormone-releasing hormone (lhrh)-agonist or orchiectomy)
boolean
C1328504 (UMLS CUI [1])
C0279492 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1272688 (UMLS CUI [2,3])
C1518041 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
C1272688 (UMLS CUI [3,3])
C0029189 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C1272688 (UMLS CUI [4,3])
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