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])
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])