ID

36927

Beschreibung

Pilot Study of Mobilization and Treatment of Disseminated Tumor Cells in Men With Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02478125

Link

https://clinicaltrials.gov/show/NCT02478125

Stichworte

Versionen (2)
  1. 21.06.19 21.06.19 -
  2. 17.09.21 17.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02478125

Englisch

Eligibility Prostate Cancer NCT02478125

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
Beschreibung

Informed Consent | Comprehension Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
2. be willing/able to adhere to the prohibitions and restrictions specified in this protocol
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
3. male aged 18 years and above
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
4. eastern cooperative group (ecog) performance status ≤2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. documented histologically confirmed adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
6. metastatic prostate cancer to the bone as documented by positive bone scan imaging
Beschreibung

Prostate Carcinoma Metastatic in the Bone | Bone scan Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C1335505
UMLS CUI [2,1]
C0203668
UMLS CUI [2,2]
C1514241
7. patient must be eligible for chemotherapy with docetaxel
Beschreibung

Eligibility Chemotherapy Docetaxel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0246415
8. patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising psa (per prostate cancer working group 2 [pcwg2] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dl).
Beschreibung

Hormone refractory prostate cancer | Raised prostate specific antigen | Castration Levels of Testosterone Serum testosterone measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2]
C0178415
UMLS CUI [3,1]
C4289828
UMLS CUI [3,2]
C0428413
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have known allergies, hypersensitivity, or intolerance to docetaxel or dexamethasone or their excipients
Beschreibung

Hypersensitivity Docetaxel | Intolerance to Docetaxel | Dexamethasone allergy | Intolerance to Dexamethasone | Hypersensitivity Docetaxel Excipient | Intolerance to Docetaxel Excipient | Hypersensitivity Dexamethasone Excipient | Intolerance to Dexamethasone Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0246415
UMLS CUI [3]
C0571611
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0011777
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0246415
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0246415
UMLS CUI [6,3]
C0015237
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0011777
UMLS CUI [7,3]
C0015237
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0011777
UMLS CUI [8,3]
C0015237
2. prior pelvic radiation (e.g. external beam, brachytherapy, etc) that, in the opinion of the investigator, may lead to decreased bone marrow cellularity in a marrow sample obtained from a pelvic bone marrow biopsy
Beschreibung

Radiotherapy to pelvis Resulting in Decreased bone marrow cellularity | Teleradiotherapy procedure | Brachytherapy | Bone marrow specimen Bone marrow biopsy Pelvis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C4229580
UMLS CUI [2]
C0419095
UMLS CUI [3]
C0006098
UMLS CUI [4,1]
C0438737
UMLS CUI [4,2]
C0005954
UMLS CUI [4,3]
C0030797
3. ongoing systemic therapy (other than a gnrh agonist/antagonist) for prostate cancer including, but not limited to:
Beschreibung

Systemic therapy Prostate carcinoma | Exception GnRH Agonist | Exception GnRH antagonist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1518041
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1268855
1. cyp-17 inhibitors (e.g. ketoconazole, abiraterone)
Beschreibung

CYP17 Inhibitor | Ketoconazole | abiraterone

Datentyp

boolean

Alias
UMLS CUI [1]
C3160096
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0754011
2. antiandrogens (e.g. bicalutamide, nilutamide)
Beschreibung

Androgen Antagonists | bicalutamide | nilutamide

Datentyp

boolean

Alias
UMLS CUI [1]
C0002842
UMLS CUI [2]
C0285590
UMLS CUI [3]
C0068771
3. second generation antiandrogens (e.g. enzalutamide)
Beschreibung

Androgen Antagonists Generation second | enzalutamide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205436
UMLS CUI [2]
C3496793
4. immunotherapy (e.g. sipuleucel-t, ipilimumab)
Beschreibung

Immunotherapy | sipuleucel-T | ipilimumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C1706668
UMLS CUI [3]
C1367202
5. chemotherapy (e.g. docetaxel, cabazitaxel)
Beschreibung

Chemotherapy | docetaxel | cabazitaxel

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0246415
UMLS CUI [3]
C2830183
4. prior radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153, etc) within the past year
Beschreibung

Radiopharmaceuticals | Radium-223 | Strontium-89 | Samarium-153

Datentyp

boolean

Alias
UMLS CUI [1]
C0182638
UMLS CUI [2]
C0303282
UMLS CUI [3]
C0281385
UMLS CUI [4]
C0677942
5. have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Beschreibung

Condition compromises Patient safety | Condition compromises Clinical Trial | Condition Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0525058
6. active infection or other medical condition that would make corticosteroids (i.e. dexamethasone) use contraindicated
Beschreibung

Communicable Disease | Other medical condition | Adrenal Cortex Hormones Contraindicated | Dexamethasone Contraindicated

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C3843040
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1444657
UMLS CUI [4,1]
C0011777
UMLS CUI [4,2]
C1444657
7. uncontrolled hypertension (systolic bp ≥ 160 mmhg or diastolic bp ≥ 95 mmhg) patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Beschreibung

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Exception Antihypertensive therapy Control of blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0585941
UMLS CUI [4,3]
C1753303
8. severe hepatic impairment (child-pugh class c)
Beschreibung

Hepatic impairment Severe Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2347612
9. history of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
Beschreibung

Pituitary dysfunction | Dysfunction adrenal

Datentyp

boolean

Alias
UMLS CUI [1]
C0281947
UMLS CUI [2]
C0549609
10. have poorly controlled diabetes (hgb a1c ≥ 8%)
Beschreibung

Poorly controlled diabetes mellitus | Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0474680
11. any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
Beschreibung

Psychological Factors Interfere with Protocol Compliance | Factor Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033898
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
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Ähnliche Modelle

Eligibility Prostate Cancer NCT02478125

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Comprehension Study Protocol
Item
1. have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Protocol Compliance
Item
2. be willing/able to adhere to the prohibitions and restrictions specified in this protocol
boolean
C0525058 (UMLS CUI [1])
Gender | Age
Item
3. male aged 18 years and above
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
4. eastern cooperative group (ecog) performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
5. documented histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Prostate Carcinoma Metastatic in the Bone | Bone scan Positive
Item
6. metastatic prostate cancer to the bone as documented by positive bone scan imaging
boolean
C1335505 (UMLS CUI [1])
C0203668 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Eligibility Chemotherapy Docetaxel
Item
7. patient must be eligible for chemotherapy with docetaxel
boolean
C1548635 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0246415 (UMLS CUI [1,3])
Hormone refractory prostate cancer | Raised prostate specific antigen | Castration Levels of Testosterone Serum testosterone measurement
Item
8. patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising psa (per prostate cancer working group 2 [pcwg2] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dl).
boolean
C1328504 (UMLS CUI [1])
C0178415 (UMLS CUI [2])
C4289828 (UMLS CUI [3,1])
C0428413 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Docetaxel | Intolerance to Docetaxel | Dexamethasone allergy | Intolerance to Dexamethasone | Hypersensitivity Docetaxel Excipient | Intolerance to Docetaxel Excipient | Hypersensitivity Dexamethasone Excipient | Intolerance to Dexamethasone Excipient
Item
1. have known allergies, hypersensitivity, or intolerance to docetaxel or dexamethasone or their excipients
boolean
C0020517 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C0571611 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0011777 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0246415 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C1744706 (UMLS CUI [6,1])
C0246415 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
C0020517 (UMLS CUI [7,1])
C0011777 (UMLS CUI [7,2])
C0015237 (UMLS CUI [7,3])
C1744706 (UMLS CUI [8,1])
C0011777 (UMLS CUI [8,2])
C0015237 (UMLS CUI [8,3])
Radiotherapy to pelvis Resulting in Decreased bone marrow cellularity | Teleradiotherapy procedure | Brachytherapy | Bone marrow specimen Bone marrow biopsy Pelvis
Item
2. prior pelvic radiation (e.g. external beam, brachytherapy, etc) that, in the opinion of the investigator, may lead to decreased bone marrow cellularity in a marrow sample obtained from a pelvic bone marrow biopsy
boolean
C1536155 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C4229580 (UMLS CUI [1,3])
C0419095 (UMLS CUI [2])
C0006098 (UMLS CUI [3])
C0438737 (UMLS CUI [4,1])
C0005954 (UMLS CUI [4,2])
C0030797 (UMLS CUI [4,3])
Systemic therapy Prostate carcinoma | Exception GnRH Agonist | Exception GnRH antagonist
Item
3. ongoing systemic therapy (other than a gnrh agonist/antagonist) for prostate cancer including, but not limited to:
boolean
C1515119 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1518041 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1268855 (UMLS CUI [3,2])
CYP17 Inhibitor | Ketoconazole | abiraterone
Item
1. cyp-17 inhibitors (e.g. ketoconazole, abiraterone)
boolean
C3160096 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0754011 (UMLS CUI [3])
Androgen Antagonists | bicalutamide | nilutamide
Item
2. antiandrogens (e.g. bicalutamide, nilutamide)
boolean
C0002842 (UMLS CUI [1])
C0285590 (UMLS CUI [2])
C0068771 (UMLS CUI [3])
Androgen Antagonists Generation second | enzalutamide
Item
3. second generation antiandrogens (e.g. enzalutamide)
boolean
C0002842 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C3496793 (UMLS CUI [2])
Immunotherapy | sipuleucel-T | ipilimumab
Item
4. immunotherapy (e.g. sipuleucel-t, ipilimumab)
boolean
C0021083 (UMLS CUI [1])
C1706668 (UMLS CUI [2])
C1367202 (UMLS CUI [3])
Chemotherapy | docetaxel | cabazitaxel
Item
5. chemotherapy (e.g. docetaxel, cabazitaxel)
boolean
C0392920 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
C2830183 (UMLS CUI [3])
Radiopharmaceuticals | Radium-223 | Strontium-89 | Samarium-153
Item
4. prior radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153, etc) within the past year
boolean
C0182638 (UMLS CUI [1])
C0303282 (UMLS CUI [2])
C0281385 (UMLS CUI [3])
C0677942 (UMLS CUI [4])
Condition compromises Patient safety | Condition compromises Clinical Trial | Condition Preventing Protocol Compliance
Item
5. have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Communicable Disease | Other medical condition | Adrenal Cortex Hormones Contraindicated | Dexamethasone Contraindicated
Item
6. active infection or other medical condition that would make corticosteroids (i.e. dexamethasone) use contraindicated
boolean
C0009450 (UMLS CUI [1])
C3843040 (UMLS CUI [2])
C0001617 (UMLS CUI [3,1])
C1444657 (UMLS CUI [3,2])
C0011777 (UMLS CUI [4,1])
C1444657 (UMLS CUI [4,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Exception Antihypertensive therapy Control of blood pressure
Item
7. uncontrolled hypertension (systolic bp ≥ 160 mmhg or diastolic bp ≥ 95 mmhg) patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0585941 (UMLS CUI [4,2])
C1753303 (UMLS CUI [4,3])
Hepatic impairment Severe Child-Pugh Classification
Item
8. severe hepatic impairment (child-pugh class c)
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,3])
Pituitary dysfunction | Dysfunction adrenal
Item
9. history of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
boolean
C0281947 (UMLS CUI [1])
C0549609 (UMLS CUI [2])
Poorly controlled diabetes mellitus | Hemoglobin A1c measurement
Item
10. have poorly controlled diabetes (hgb a1c ≥ 8%)
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Psychological Factors Interfere with Protocol Compliance | Factor Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
Item
11. any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
boolean
C0033898 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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