Eligibility Prostate Cancer NCT02478125

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StudyEvent: Eligibility
1. Eligibility Prostate Cancer NCT02478125

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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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Eligibility Prostate Cancer NCT02478125