ID

24331

Beschrijving

A Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC); ODM derived from: https://clinicaltrials.gov/show/NCT00571675

Link

https://clinicaltrials.gov/show/NCT00571675

Trefwoorden

Versies (2)
  1. 30-07-17 30-07-17 -
  2. 30-07-17 30-07-17 -
Geüploaded op

30 juli 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Hormone Refractory Prostate Cancer NCT00571675

Engels

Eligibility Hormone Refractory Prostate Cancer NCT00571675

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males age ≥ 18 years with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (e.g. any t, any n, m1a-c) based on bone scan, ct scan, or mri scan.
Beschrijving

Gender | Age | Adenocarcinoma of the prostate metastatic Bone scan | X-Ray Computed Tomography | Magnetic Resonance Imaging

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0862636
UMLS CUI [3,2]
C0203668
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
2. progression of disease despite androgen deprivation (androgen ablation or surgical castration) and anti-androgen withdrawal as documented by one or more of the following.
Beschrijving

Disease Progression | Androgen suppression | Male Castration | Androgen Antagonists Withdrawal

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C1515985
UMLS CUI [3]
C0007347
UMLS CUI [4,1]
C0002842
UMLS CUI [4,2]
C2349954
progression of measurable disease per recist
Beschrijving

Measurable Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0242656
bone scan progression, defined as the appearance of ≥ 2 new lesions on bone scan, attributable to prostate cancer
Beschrijving

Disease Progression Bone scan | Lesion New Quantity Bone scan | Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0203668
UMLS CUI [3]
C0600139
rising psa, as defined by increasing levels on at least two consecutive assessments, following a prior assessment taken as a reference value, where all of the following are met:
Beschrijving

Raised prostate specific antigen Assessment Quantity | Assessment Previous Reference

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C1706462
the assessments are at least one week apart, with the first assessment at least one week later than the reference value
Beschrijving

Assessment Week Quantity Separate

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0443299
progressive increase in the two assessments after the reference value, without an intervening decrease between assessments.
Beschrijving

Increase Progressive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442805
UMLS CUI [1,2]
C0205329
the last value prior to study entry is ≥ 2 ng/ml
Beschrijving

Result Last

Datatype

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C1517741
3. serum testosterone level ≤ 50 ng/dl post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a lhrh agonist or antagonist.
Beschrijving

Serum testosterone measurement Post Orchiectomy | Serum testosterone measurement while Androgen suppression | LHRH Agonist | LHRH antagonists

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428413
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0029189
UMLS CUI [2,1]
C0428413
UMLS CUI [2,2]
C0750519
UMLS CUI [2,3]
C1515985
UMLS CUI [3]
C1518041
UMLS CUI [4,1]
C0023610
UMLS CUI [4,2]
C0243076
4. at least 2 weeks since ketoconazole or systemic steroids (any dose); 2 weeks since prior flutamide, megestrol, or aminoglutethimide; and at least 2 weeks since prior bicalutamide or nilutamide
Beschrijving

Ketoconazole Previous | Systemic steroids Previous | Flutamide Previous | Megestrol Previous | Aminoglutethimide Previous | Bicalutamide Previous | Nilutamide Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2825233
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0016384
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C0025175
UMLS CUI [4,2]
C0205156
UMLS CUI [5,1]
C0002555
UMLS CUI [5,2]
C0205156
UMLS CUI [6,1]
C0285590
UMLS CUI [6,2]
C0205156
UMLS CUI [7,1]
C0068771
UMLS CUI [7,2]
C0205156
5. radiation therapy and/or therapy with samarium must have been completed 4 weeks prior to first dose of therapy. strontium therapy must have been completed at least 12 weeks prior to the first dose of therapy. the patient must have recovered from all treatment-related toxicities.
Beschrijving

Therapeutic radiology procedure Completed | Samarium Treatment completed | Strontium Treatment completed | Prior Therapy Toxicity Patient recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0036147
UMLS CUI [2,2]
C0580352
UMLS CUI [3,1]
C0038467
UMLS CUI [3,2]
C0580352
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C0600688
UMLS CUI [4,3]
C1115804
6. ecog performance status ≤ 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
7. able to swallow and retain oral medication
Beschrijving

Able to swallow Oral medication | Oral medication Retain Ability

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0085732
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. received prior chemotherapy (including estramustine phosphate [estracyt]) for hrpc. adjuvant chemotherapy (including docetaxel) is allowed provided that progression of disease occurred ≥ 6 months after the completion of adjuvant therapy.
Beschrijving

Chemotherapy Hormone refractory prostate cancer | Estramustine phosphate | Estracyt | Chemotherapy, Adjuvant | docetaxel | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1328504
UMLS CUI [2]
C0356799
UMLS CUI [3]
C0014911
UMLS CUI [4]
C0085533
UMLS CUI [5]
C0246415
UMLS CUI [6]
C0242656
2. patients must not be receiving concurrent anti-androgen hormonal therapy for hrpc (lhrh directed therapies are acceptable to maintain castrate levels of testosterone).
Beschrijving

Antiandrogen therapy hormonal Hormone refractory prostate cancer | LHRH | Testosterone level Male Castration Maintenance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0458083
UMLS CUI [1,3]
C1328504
UMLS CUI [2]
C0023610
UMLS CUI [3,1]
C0428412
UMLS CUI [3,2]
C0007347
UMLS CUI [3,3]
C0024501
3. treatment with monoclonal antibody (e.g., vegf targeting antibody) or prostate cancer vaccine within 45 days prior to the first dose of study treatment. acute toxicities from prior therapy must have resolved to grade ≤ 1.
Beschrijving

Monoclonal Antibodies | Antibody Targeting Vascular Endothelial Growth Factors | Prostate carcinoma Vaccine | Prior Therapy Toxicity resolved | Toxicity Grade

Datatype

boolean

Alias
UMLS CUI [1]
C0003250
UMLS CUI [2,1]
C0003241
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C1256770
UMLS CUI [3,1]
C0600139
UMLS CUI [3,2]
C0042210
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C0600688
UMLS CUI [4,3]
C1514893
UMLS CUI [5]
C2826262
4. known history of or clinical evidence of central nervous system (cns) metastases or leptomeningeal carcinomatosis
Beschrijving

CNS metastases | Meningeal Carcinomatosis

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
5. active secondary malignancy or history of other malignancy within the last 5 years
Beschrijving

Secondary Malignant Neoplasm | Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C3266877
UMLS CUI [2]
C0006826
6. prior history of radiation therapy to ≥ 30% of the bone marrow
Beschrijving

Therapeutic radiology procedure Bone Marrow Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
7. peripheral neuropathy of ≥ grade 2
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
8. patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
Beschrijving

Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Diseases | Partial obstruction of small bowel | Small bowel obstruction Complete

Datatype

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
UMLS CUI [3]
C1304699
UMLS CUI [4]
C0192601
UMLS CUI [5]
C0009324
UMLS CUI [6]
C0021390
UMLS CUI [7]
C0281936
UMLS CUI [8,1]
C0235329
UMLS CUI [8,2]
C0205197
9. class 3 or 4 cardiac disease as defined by the new york heart association functional classification
Beschrijving

Heart Disease New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
10. known active symptomatic fungal, bacterial and/or viral infection including active hiv. note: screening for viruses is not required.
Beschrijving

Mycose Symptomatic | Bacterial Infection Symptomatic | Virus Disease Symptomatic | HIV Infection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026946
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0004623
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0019693
11. psychiatric illness/social situations that would limit compliance with the study requirements.
Beschrijving

Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
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Similar models

Eligibility Hormone Refractory Prostate Cancer NCT00571675

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Adenocarcinoma of the prostate metastatic Bone scan | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
1. males age ≥ 18 years with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (e.g. any t, any n, m1a-c) based on bone scan, ct scan, or mri scan.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0862636 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
Disease Progression | Androgen suppression | Male Castration | Androgen Antagonists Withdrawal
Item
2. progression of disease despite androgen deprivation (androgen ablation or surgical castration) and anti-androgen withdrawal as documented by one or more of the following.
boolean
C0242656 (UMLS CUI [1])
C1515985 (UMLS CUI [2])
C0007347 (UMLS CUI [3])
C0002842 (UMLS CUI [4,1])
C2349954 (UMLS CUI [4,2])
Measurable Disease Progression
Item
progression of measurable disease per recist
boolean
C1513041 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Disease Progression Bone scan | Lesion New Quantity Bone scan | Prostate carcinoma
Item
bone scan progression, defined as the appearance of ≥ 2 new lesions on bone scan, attributable to prostate cancer
boolean
C0242656 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0203668 (UMLS CUI [2,4])
C0600139 (UMLS CUI [3])
Raised prostate specific antigen Assessment Quantity | Assessment Previous Reference
Item
rising psa, as defined by increasing levels on at least two consecutive assessments, following a prior assessment taken as a reference value, where all of the following are met:
boolean
C0178415 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1706462 (UMLS CUI [2,3])
Assessment Week Quantity Separate
Item
the assessments are at least one week apart, with the first assessment at least one week later than the reference value
boolean
C1516048 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0443299 (UMLS CUI [1,4])
Increase Progressive
Item
progressive increase in the two assessments after the reference value, without an intervening decrease between assessments.
boolean
C0442805 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Result Last
Item
the last value prior to study entry is ≥ 2 ng/ml
boolean
C1274040 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Serum testosterone measurement Post Orchiectomy | Serum testosterone measurement while Androgen suppression | LHRH Agonist | LHRH antagonists
Item
3. serum testosterone level ≤ 50 ng/dl post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a lhrh agonist or antagonist.
boolean
C0428413 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0029189 (UMLS CUI [1,3])
C0428413 (UMLS CUI [2,1])
C0750519 (UMLS CUI [2,2])
C1515985 (UMLS CUI [2,3])
C1518041 (UMLS CUI [3])
C0023610 (UMLS CUI [4,1])
C0243076 (UMLS CUI [4,2])
Ketoconazole Previous | Systemic steroids Previous | Flutamide Previous | Megestrol Previous | Aminoglutethimide Previous | Bicalutamide Previous | Nilutamide Previous
Item
4. at least 2 weeks since ketoconazole or systemic steroids (any dose); 2 weeks since prior flutamide, megestrol, or aminoglutethimide; and at least 2 weeks since prior bicalutamide or nilutamide
boolean
C0022625 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0016384 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0025175 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0002555 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C0285590 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
C0068771 (UMLS CUI [7,1])
C0205156 (UMLS CUI [7,2])
Therapeutic radiology procedure Completed | Samarium Treatment completed | Strontium Treatment completed | Prior Therapy Toxicity Patient recovered
Item
5. radiation therapy and/or therapy with samarium must have been completed 4 weeks prior to first dose of therapy. strontium therapy must have been completed at least 12 weeks prior to the first dose of therapy. the patient must have recovered from all treatment-related toxicities.
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0036147 (UMLS CUI [2,1])
C0580352 (UMLS CUI [2,2])
C0038467 (UMLS CUI [3,1])
C0580352 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0600688 (UMLS CUI [4,2])
C1115804 (UMLS CUI [4,3])
ECOG performance status
Item
6. ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Able to swallow Oral medication | Oral medication Retain Ability
Item
7. able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Hormone refractory prostate cancer | Estramustine phosphate | Estracyt | Chemotherapy, Adjuvant | docetaxel | Disease Progression
Item
1. received prior chemotherapy (including estramustine phosphate [estracyt]) for hrpc. adjuvant chemotherapy (including docetaxel) is allowed provided that progression of disease occurred ≥ 6 months after the completion of adjuvant therapy.
boolean
C0392920 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
C0356799 (UMLS CUI [2])
C0014911 (UMLS CUI [3])
C0085533 (UMLS CUI [4])
C0246415 (UMLS CUI [5])
C0242656 (UMLS CUI [6])
Antiandrogen therapy hormonal Hormone refractory prostate cancer | LHRH | Testosterone level Male Castration Maintenance
Item
2. patients must not be receiving concurrent anti-androgen hormonal therapy for hrpc (lhrh directed therapies are acceptable to maintain castrate levels of testosterone).
boolean
C0279492 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C1328504 (UMLS CUI [1,3])
C0023610 (UMLS CUI [2])
C0428412 (UMLS CUI [3,1])
C0007347 (UMLS CUI [3,2])
C0024501 (UMLS CUI [3,3])
Monoclonal Antibodies | Antibody Targeting Vascular Endothelial Growth Factors | Prostate carcinoma Vaccine | Prior Therapy Toxicity resolved | Toxicity Grade
Item
3. treatment with monoclonal antibody (e.g., vegf targeting antibody) or prostate cancer vaccine within 45 days prior to the first dose of study treatment. acute toxicities from prior therapy must have resolved to grade ≤ 1.
boolean
C0003250 (UMLS CUI [1])
C0003241 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C1256770 (UMLS CUI [2,3])
C0600139 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0600688 (UMLS CUI [4,2])
C1514893 (UMLS CUI [4,3])
C2826262 (UMLS CUI [5])
CNS metastases | Meningeal Carcinomatosis
Item
4. known history of or clinical evidence of central nervous system (cns) metastases or leptomeningeal carcinomatosis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Secondary Malignant Neoplasm | Malignant Neoplasms
Item
5. active secondary malignancy or history of other malignancy within the last 5 years
boolean
C3266877 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Therapeutic radiology procedure Bone Marrow Percentage
Item
6. prior history of radiation therapy to ≥ 30% of the bone marrow
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Peripheral Neuropathy CTCAE Grades
Item
7. peripheral neuropathy of ≥ grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Diseases | Partial obstruction of small bowel | Small bowel obstruction Complete
Item
8. patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C1304699 (UMLS CUI [3])
C0192601 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
C0021390 (UMLS CUI [6])
C0281936 (UMLS CUI [7])
C0235329 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
Heart Disease New York Heart Association Classification
Item
9. class 3 or 4 cardiac disease as defined by the new york heart association functional classification
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Mycose Symptomatic | Bacterial Infection Symptomatic | Virus Disease Symptomatic | HIV Infection
Item
10. known active symptomatic fungal, bacterial and/or viral infection including active hiv. note: screening for viruses is not required.
boolean
C0026946 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0004623 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4])
Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
11. psychiatric illness/social situations that would limit compliance with the study requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
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